Regulatory Affairs Director remote jobs

The California Independent System Operator (ISO) manages the flow of electricity across the high-voltage, long-distance power lines that make up 80 percent of California's power grid. We safeguard the economy and well-being of 30 million Californians by operating the grid reliably 24/7. As the impartial grid operator, the California ISO opens access to the wholesale power market that is designed to diversify resources and lower prices. It also grants equal access to 25,865 circuit-miles of power lines and reduces barriers to diverse resources competing to bring power to customers. The California ISO's function is often compared to that of air traffic controllers. It would be grossly unfair for air traffic controllers to represent one airline and profit from allowing that company's planes to go through before others. In the same way, the California ISO operates independently-managing the electron traffic on a power grid we do not own-making sure electricity is safely delivered to utilities and consumers on time and reliably. The California ISO is committed to the health, safety, and work/life integration of its employees, and is proud to offer flexible work arrangements. This position is available in a hybrid or local remote schedule. Relocation assistance is available. Job Description Under the general direction of the Vice President, manages the day-to-day operations and staff responsible for both external and internal engagement on all California state regulatory matters. For external engagement, manages the ISO's participation in processes at the California Public Utilities Commission (CPUC), the California Energy Commission (CEC) and other state agencies, as appropriate. Communicates ISO positions to agency policy makers and staff and represents the ISO in a variety of settings including agency meetings and public forums. Coordinates regular, ongoing interaction between the ISO and state regulatory agencies. Engages in key agency proceedings to ensure that the ISO's objectives are met. For internal engagement, manages the California Regulatory Affairs team's participation in various ISO processes and fora, including market design and infrastructure policy stakeholder processes. What You Will Be Doing: Manages the day-to-day for the California Regulatory Affairs group operations and staff. Responsible for providing broad direction and guidance, identifies training needs, coaches and gives feedback on employee performance, develops staff performance plans, makes recommendations with respect to the hiring, firing, advancement, promotion or any other change in the status of direct reports, and performs related activities as appropriate. In coordination with and as directed by the VP, develop ISO policy positions to guide interactions between state regulatory agencies and the ISO. Actively coordinates with other members of the Market Design and Analysis division and across the ISO. Escalates to VP of MD&A and other senior management and executives as appropriate to ensure California Regulatory Affairs team and leadership are kept apprised on the most recent developments and ISO teams are aware of regulatory concerns. Manages ISO coordination with state regulatory agencies on topics that involve close collaboration with state regulatory agency processes including but not limited to infrastructure and resource planning, long-term demand forecasting, and demand response and distributed energy resource integration. Actively participates and/or monitors agency proceedings and ISO internal processes that have a state regulatory impact; ensures that ISO positions and messages are internally aligned and are communicated effectively to state regulators and staff and vice versa; assigns to direct reports both internal and external engagements to ensure issues are appropriately prioritized and messaging is aligned. Educates policy makers and staff of state regulatory agencies on the role and responsibilities of the ISO, as well as its commitment to achieving state and regional energy and environmental goals. Provides briefings, assembles documentation, and hosts discussions on key ISO issues and objectives. Ensures that state agencies are welcomed into ISO stakeholder processes, and that their comments receive due consideration. Builds coalitions and alliances with other entities to advance ISO objectives in state regulatory forums. Maintains and enhances relationships with parties as new policy matters are deliberated. Qualifications Level of Education and Discipline: A Bachelor's degree (BA, BS) or equivalent education, training or experience in Engineering, Economics, Policy Administration, Business, Law or related field. Master's Degree preferred. Amount of Experience: Equivalent years of education and training, plus ten (10) or more years related experience, including five (5) years at senior advisor or manager level or equivalent. Type of Experience: Experience in the electric utility industry managing strategic relationships with government and/or regulatory agencies. Fundamental knowledge of electric power systems and markets. Experience leading and facilitating team projects. Experience presenting electricity market concepts and initiatives to mixed audiences including industry stakeholders, legislators and other policy makers. Experience interfacing with and managing communication between Executive and Commissioner level stakeholders. Additional Skills and Abilities: Ability to think strategically and devise solutions to problems in keeping with multiple considerations. Excellent leadership and management abilities with experience coaching and developing others. Must demonstrate sound judgment and critical thinking when making decisions. Must be able to work effectively in a team environment as team leader, facilitator and team member. Strong analytical and quantitative skills required. Excellent interpersonal, communication and writing skills required, including the ability to effectively communicate complex materials and concepts. Must be able to handle a dynamic and changing work environment, and work well independently. Additional Information The pay range for the Direcctor, California Regulatory Affairs is $196,875 - $328,125 annually. All your information will be kept confidential according to EEO guidelines.

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline. We are seeking a highly motivated Director, Regulatory Affairs, reporting to the VP of Regulatory Affairs, who will lead and oversee development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration for assigned programs. The Director will represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late-stage development programs. Responsibilities: Independently serve as the regulatory representative on cross-functional teams. Communicate regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed. Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory results and ensure strategic integration of regulatory considerations into program plans. Independently lead the central messaging, preparation, and submission of high-quality, regulatory-complaint regulatory dossiers. Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teams. Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements. Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines. Ensure accuracy and consistency of regulatory submissions and correspondence. Handle vendor/consultant roles, where applicable. Serve as the regulatory point of contact for interactions with FDA and other global health authorities. Critically review nonclinical and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provide regulatory strategic guidance on documents and submission plans to align with study and company objectives. Interact directly with regulatory agencies; manage agency interactions. Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations. May assist with due diligence to support business development opportunities. Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations. Qualifications: B.S./M.S. degree in a scientific discipline or related field. Minimum of 10 years of Pharmaceutical Regulatory Affairs experience; experience in neuropsychiatric indications preferred. Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required. Experience supporting development stage programs (Phase 1-3). Experience with IND/CTA and license applications. Experience with management of commercial product(s) highly desirable. Ability to work in a hybrid environment and with distributed teams; startup/small company experience preferred. Self-starter who can independently lead assigned projects. Experience in central nervous system disease research a plus. Strong analytical skills, problem solving ability, and presentation skills. Excellent communication and interpersonal skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds. 2026 Company benefits include: Medical, dental, vision, and life insurance 401(k) plan: Neumora matches 50% of an employee's eligible contribution, up to the first 6% of salary (up to 3% employer contribution) Company Equity (New Hire Awards, Annual Awards, ESPP) Annual paid time off: Accrued Vacation Days: 15 days per year Sick Days: 10 days per year Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability Discretionary year-end bonus The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range:$221,675 -$244,434 Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our generation by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases. Neumora's mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients. Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. Responsibilities and Accountabilities: Strategic Leadership: Define and implement global CMC regulatory strategies with a strong focus on North American requirements. Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. Policy & Advocacy: Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. Cross-Functional Collaboration: Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. External Engagement: Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. Lead advocacy initiatives for innovative technologies and precedent-setting projects. Operational Excellence: Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). Ensure consistency and quality in dossier preparation across regions. Expected Key Accountabilities from Global Regulatory Aspects Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility.

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Director of Regulatory Affairs, Advertising & Promotion will own and drive regulatory leadership and oversight for advertising, promotional, and non-promotional activities supporting cell therapy, biologics, combination products and medical devices. This individual will be responsible for ensuring that all promotional materials and communications are scientifically accurate, compliant with FDA and other global regulatory standards, and aligned with company objectives. The role requires strong expertise in regulatory requirements for advanced therapies and combination products, the ability to chair and guide promotional review processes, and proven leadership in cross-functional and regulatory authority interactions. Schedule: This position is in-office from Monday - Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. Position Scope: Enable the business by providing regulatory guidance and oversight for U.S. and global advertising and promotional activities supporting cell therapy, biologics, combination products and medical devices. Leverage strong written/verbal communication skills to review and approve all promotional, non-promotional, and scientific materials to ensure accuracy, fair balance, and compliance with applicable regulations. Partner and build strong relationships cross-functionally with Medical, Legal, Quality, and Commercial to ensure promotional content is scientifically rigorous and compliant. Chair high-volume Medical, Legal, Regulatory (MLR) meetings for Vericel's brands sharing the regulatory perspective with the goal of enabling business and mitigating risk. Serve as primary contact and SME with FDA OPDP/APLB and other health authorities. Maintain deep expertise in FDA regulations, guidance documents, and enforcement actions pertaining to advertising and promotion; monitor regulatory developments and communicate changes and implications to internal stakeholders. Ensure the promotional review process is efficient, consistent, and aligned with regulatory expectations, with the goal of supporting business agility while minimizing compliance risk. Develop, implement, and continuously improve processes, SOPs, and best practices for the review and approval of advertising and promotional materials, including integrating new AI technologies. Provide training and education to internal teams on requirements for prescription product promotion. Partner with and advise product development and brand teams on advertising and promotional considerations during product development, launch planning, and lifecycle management. Participate in or lead regulatory project team and labeling meetings, providing strategic input on promotional implications of proposed labeling, new claims, and campaign concepts. Qualifications: Bachelor of Science in a scientific discipline; Master's degree preferred. 10+ years direct Regulatory Affairs experience with at least 5+ years of experience in regulatory review of promotional materials for prescription drug or biologic products. Proven track record in managing promotion review committees (e.g. PRC) or other regulatory governance forums. Deep knowledge of FDA / OPDP / APLB regulations, global promotional guidance and enforcement trends in advertising and promotion. Experience in negotiations and/or formal interactions with regulatory authorities (OPDP/APLB or equivalent) preferred. Demonstrated ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Quality) and drive alignment under regulatory constraints. Strong team player that has a customer service approach and is solution oriented. Attention to detail, strong written and verbal communication skills and the ability to work individually, within a multidisciplinary team. Experience authoring and implementing SOPs, review processes, training materials for promotional compliance. Proven success in managing large, complex, time-sensitive projects in a regulated environment. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $188,000 to $235,000 annually. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. Stay Connected with Telix for Future or Upcoming Regulatory Affairs - CMC Opportunities Telix is always looking to connect with great talent in the market! While we may not have the position you're looking for open today, we'd love for you to share your information with us for future openings. This post is not for a specific role or territory, but we can reach out when an opening comes available. See Yourself at Telix The Global Regulatory CMC team is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. This team will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs. Key Accountabilities Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness. Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes. Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations. Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content. Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed. Education and Experience Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred. Experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry. Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations. Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders. Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks. Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies. Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3. Interested in joining our mission? Submit your information and let's stay connected! At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

This is a fully remote role. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. This role will be within our FSP group. We have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory strategy across client's development portfolio. This role oversees end-to-end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country-level customization strategies, and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. The Director, Clinical Regulatory Affairs partners closely with Clinical Operations, Clinical Development, Safety, and CMC leadership and serves as a key point of contact for global regulatory agencies on clinical matters. Key Responsibilities Strategic Leadership & Regulatory Planning Define and lead the company's global clinical regulatory strategy, ensuring alignment across programs, territories, and development milestones. Serve as the senior regulatory advisor to program teams, helping shape clinical development plans, scientific strategies, and geographic expansion. Stay abreast of the regulatory landscape and regulatory requirements. Anticipate regulatory challenges, conduct strategic risk assessments, and propose clear, data-driven mitigation strategies. Represent Regulatory Affairs leadership in governance forums, providing decision-making support and regulatory insights to senior management. Global Submission Strategy & Execution Oversee the planning, authorship, review, and delivery of all major clinical regulatory submissions, including: New Drug Application (NDA) IND/CTA filings and amendments Health authority pre-submission and post-submission packages DSURs, Annual Reports, SUSAR submissions Protocols, IBs, and related clinical documentation Lead cross-functional submission teams with CROs, ensuring clarity of roles, timelines, and quality expectations. Establish and continuously optimize submission processes, tools, templates, and governance standards. Core Dossier Management & Country Customization Direct the development, release, and lifecycle management of global core clinical dossiers, ensuring scientific rigor, regulatory compliance, and internal alignment. Drive strategies for efficient global rollout, including harmonization across regions and scalable dossier architecture. Provide executive-level guidance to regional teams on country-specific customization, ensuring adherence to local regulations, formats, language requirements, and health authority expectations. Approve localized submissions for strategic consistency and regulatory integrity. Regulatory RFIs & Agency Interactions Oversee the development of robust, scientifically sound, and timely Requests for Information (RFI) responses, ensuring alignment with overall regulatory and clinical strategy. Lead preparation for and participation in key regulatory interactions (FDA, EMA, MHRA, PMDA, and other agencies). Clinical Operations Partnership & Trial Execution Partner with Clinical Operations leadership to ensure regulatory considerations are fully integrated into trial startup, conduct, and closeout. Guide regional feasibility and startup planning from a regulatory perspective, including country prioritization and risk management. Oversee vendor and CRO performance related to regulatory responsibilities. Ensure organization-wide inspection readiness and provide senior oversight during audits and regulatory inspections. Knowledge, Skills, Abilities Education and Experience: Bachelor's degree in life sciences or related field; advanced degree strongly preferred 12+ years of regulatory affairs experience in biotech/pharma, including 5 years of substantial leadership experience supporting global clinical programs. Demonstrated success leading global IND/CTA submissions, dossier management, and regulatory interactions. Expertise in crafting high-quality RFI responses and managing complex regulatory communications. Deep knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.). Proven experience influencing cross-functional leaders and driving alignment on regulatory strategy. Outstanding communication, leadership, and organizational skills. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Preferred Experience with biologics, gene therapies, cell therapies, or other advanced modalities. Prior responsibility for global rollout of core clinical dossiers or large-scale clinical submission programs. RAC certification or equivalent credential. Experience in fast-paced or emerging biotech environments. Physical Requirements / Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travels both domestic and international. Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Moderate mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups both internally & externally. Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

BrainChild Bio is seeking a Director, Regulatory Affairs, to lead and execute the regulatory strategy for our CAR T programs. This role will serve as BrainChild Bio's primary regulatory representative, responsible for guiding regulatory activities across preclinical, clinical, and manufacturing stages, while partnering closely with internal teams and external partners.The Director will work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. Responsibilities include developing regulatory strategies that support innovative CAR T development, preparing for and participating in FDA and ex-US health authority interactions, and ensuring documentation and filings are complete, accurate, and timely. The ideal candidate brings substantial experience in Regulatory Affairs within a clinical-stage biotech, strong working knowledge of FDA regulations for cell and gene therapy products, and the ability to operate both strategically and hands-on. We're seeking a collaborative, detail-oriented leader who thrives in a fast-moving environment and is motivated by bringing transformative therapies to patients.Responsibilities: Lead and execute regulatory strategies to support development of CAR T programs. Prepare, review, and submit INDs, amendments, and regulatory correspondence to FDA and other global health authorities. Serve as primary regulatory contact with health authorities, including FDA, EMA and other global agencies, representing BrainChild Bio in meetings and discussions. Collaborate cross-functionally with Clinical, CMC, Quality, and Patient Operations to ensure regulatory compliance and alignment with program objectives Identify risks and opportunities, providing strategic recommendations to accelerate development timelines. Advise on regulatory implications of protocols, manufacturing processes, and patient logistics. Manage regulatory timelines, submissions, and deliverables across multiple programs. Stay informed of emerging regulations, guidance documents, and industry trends specific to cell and gene therapy. Qualifications: 10+ years of regulatory affairs experience, including significant experience in cell and gene therapy, or advanced biologics. Strong working knowledge of FDA regulations and guidance for CAR T and other cell therapy products, as well as global regulatory frameworks. Demonstrated ability to develop strategic regulatory plans and execute them in a fast-paced clinical-stage biotech environment. Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution. Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders. Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies.

MedCerts - a Stride Inc. company (NYSE: LRN) - is a national online training provider strengthening the workforce through innovative eLearning solutions. Focused on certifications in high-demand areas of allied healthcare and IT, it serves individuals from all backgrounds, including the military and their families, career changers and the under- and unemployed. MedCerts delivers career training through HD-quality video-based instruction, virtual simulations, games and animations, and on-the-job training through Experiential Learning solutions. Since 2009, the company has developed over 45 career programs, trained and up-skilled more than 35,000 individuals across the country and partnered with over 500 American Job Centers and more than 1,000 healthcare and academic organizations to build talent pipelines, and provide the option of articulated college credit to our students. In 2020, MedCerts was acquired by Stride, Inc. Stride has transformed the teaching and learning experience for millions of people by providing innovative, high-quality, tech-enabled education solutions, curriculum, and programs directly to students, schools, the military, and enterprises in primary, secondary, and post-secondary settings. For more information, visit medcerts.com. The Regulatory Affairs and Compliance Director will lead the pursuit, organization, maintenance, and archival activities related to State Authorizations and Eligible Training Provider List Authorizations. Primary responsibilities include but are not limited to the submission of new and renewal applications, processing documents as required by funder organizations, monitoring outcomes for compliance, project evaluation, analyzing data and submitting reports. GENERAL DUTIES AND RESPONSIBILITIES Review and complete Master Agreements, contract, and applications for State Higher Education Boards, Workforce Investment Boards, and other regulatory entities. Completing ETPL applications for new state and regional sales territories Proactively inform leadership and sales leaders on all aspects of regulatory affairs for current statuses and future road mapping. Review and provide interpretation of proposal requirement Gather information regarding education laws, ordinances, and regulation Adding new program offerings or modifying program offerings on already approved state and regional ETPL approvals Assist all stakeholders with compliance reporting deadlines, licensing, authorization, and accreditation applications as needed Conduct research on various government agencies and identify new funding opportunities Other duties and special projects as assigned REQUIRED QUALIFICATIONS Direct, robust, and successful experience in regulatory affairs/compliance environments Bachelor's Degree is required, Master's degree is preferred Excellent oral and written communication Must have experience leading a team Work effectively in a fast-paced changing environment Ability to work under pressure and meet deadlines, while maintaining a positive attitude Ability to work independently and to carry out assignments to completion with limited guidance WORKING CONDITIONS This is a remote position in which work will be completed during normal business hours (approximately 8:30am - 5:00pm). COMPENSATION & BENEFITS: Stride, Inc. considers a person's education, experience, and qualifications, as well as the position's work location, expected quality and quantity of work, required travel (if any), external market and internal value when determining a new employee's salary level. Salaries will differ based on these factors, the position's level and expected contribution, and the employee's benefits elections. Offers will typically be in the bottom half of the range. We anticipate the salary range to be $68,598.80 - $138,674.53. Eligible employees may receive a bonus. This salary is not guaranteed, as an individual's compensation can vary based on several factors. These factors include, but are not limited to, geographic location, experience, training, education, and local market conditions. Stride offers a robust benefits package for eligible employees that can include health benefits, retirement contributions, and paid time off. Job Type Regular The above job is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. All employment is “at-will” as governed by the law of the state where the employee works. It is further understood that the “at-will” nature of employment is one aspect of employment that cannot be changed except in writing and signed by an authorized officer. If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you can request the appropriate accommodation by contacting *********************. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Stride, Inc. is an equal opportunity employer. Applicants receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or any other basis prohibited by federal, state, or local law. Stride, Inc. complies with all legally required affirmative action obligations. Applicants will not be discriminated against because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

**Job Title:** Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) **About the Job** Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. You'll be asked to solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects. This is a subject matter expert role wiht no direct reports, though there will be mentoring, training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** + Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. + Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution. + Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process. + Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. + In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. + Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business. + Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy. + Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork. + Assures alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities. + Assists in ensuring product support relationships with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates significant autonomy in carrying out assigned duties and responsibilities. **About You** + Earned Bachelor's degree (required) from an accredited four-year college or university in a Life Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions + Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred + Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data. + Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions. + Ability to generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities. + Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans. + Able to establish priorities and timelines to effectively self-manage workload. Is able to multitask exceptionally well. + Deals with people in an honest and forthright manner representing information and data accurately. **Why Choose Us** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SA \#LI-SA \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

**General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and facilitate marketing authorization in line with business objectives, and in coordination with key internal and external stakeholders. **Essential** **Functions** **of** **the** **job:** + Develop European and/or UK regulatory strategy for the designated program, and contribute to the clinical development plans to align diagnostic testing and drive integration to therapeutic development plans. + Act as the representative of European regulatory team at the global regulatory team (GRT) for the designated projects needing diagnostics, and may also be required to represent diagnostic strategies to global cross-functional teams for specific topics + Drive the strategy, providing direction and oversight for Dx/CDx and Device related content of regulatory documents, such as, CPS, CPSR, IBs, and briefing documents for interactions with European regulatory authorities or RFIs, as applicable. + Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of diagnostic submissions + Oversee and be accountable for Dx/CDx and Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review + Lead and mentor team members + Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European regulatory authorities and the UK. + Represent the BeOne European regulatory function at industry consortium (may be required). **Qualifications:** + Minimum of 10+ years' experience in the biotechnical or pharmaceutical industry with a bachelor's degree, and a minimum of 10 years' experience in a Regulatory capacity with increasing responsibility. + Seasoned negotiator, both internally and externally with a solid background in medical devices/diagnostic development regulations and associated regulatory deliverables. + Experience working with Notified Bodies and various Member State HAs to support diagnostic testing. + Sound understanding of the drug and diagnostic development process, the pharmaceutical industry and healthcare environment including Global and EU/UK regulatory requirements and policy trends + Recent experience with diagnostic testing to support clinical trials in all phases of study, is mandatory for this role. + Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism + English native speaker is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director, Global Regulatory Strategy, Dx/CDx and Medical Devices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for Vistagen's products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle. This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Vice President, Global Regulatory Affairs. Key Duties & Responsibilities: Key responsibilities of this role include, but are not limited to: * Contribute to the regulatory strategy, development, and execution for Vistagen's products, including nonclinical and clinical regulatory strategy, INDs, marketing applications, and post-approval changes. * Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goals. * Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies. * Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policies. * Oversee the preparation, review, and submission of regulatory submissions to health authorities. * Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects. * Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle. * Act as a primary regulatory point of contact for IND(s) with the U.S. FDA. * Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management. * Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practices. Qualifications: * Bachelor's degree in Life Sciences, Pharmacy, or related field. Advanced degree (Master's, PhD, or PharmD) is preferred. * 8-10 years of experience in Regulatory Affairs. * Proven track record of successful regulatory submissions and approvals in relevant markets. * Management and mentoring experience preferred. * In-depth knowledge of regulatory requirements and guidelines (e.g. FDA, ICH). * Experience with electronic submission systems (e.g. eCTD, SPL). * Regulatory writing and liaison experience is required. * Excellent written and verbal communication skills, with the ability to present complex information clearly. * Strong problem-solving abilities and attention to detail. * Strong project management and organizational skills. * Ability to work under pressure and manage competing priorities. Compensation and Benefits What we offer: * Industry competitive compensation * Performance-based bonuses * Stock options * Employee Stock Purchase Plan * 401k plan * A collaborative and innovative work environment at the forefront of biotech advancements Give your best, live wholesomely: * Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents * FSA and HAS * Basic Life Insurance 2x Earnings and AD&D * Employee Assistance Program * Healthcare advocates group to help navigate the healthcare system Work-life balance: * Unlimited paid time off * Flexible work schedule * Remote work option * Paid holidays * Mental health days * Winter shutdown * Casual work environment We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence. The anticipated salary range for candidates who will work remotely is $185,000-$215,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc. Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. Physical Demands: The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment. DISCLAIMER Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification. All Employee's have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) OVERVIEW OF THE COMPANY Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and brain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at *****************

About the Company Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals. Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel. Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization. Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies. Develop and maintain external relationships with key opinion leaders and regulatory officials. Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events. Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk. Responsible for company's product quality and reliability to meet or exceed regulatory. Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards. Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities. Support the quality system, provide effective leadership support, training, and guidance to all company personnel. Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner. Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures. Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management. Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible. Champion initiatives that contribute to global process improvements, which have a significant impact on business. Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors. Other projects or responsibilities as may be required. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job. Minimum Qualifications - Education and Experience A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position. Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role. Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions. Excellent working knowledge of the US, European and Asian regulations for drugs and biologics. Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. Must be able to travel (US/international) up to 25%. Preferred Qualifications - Education and Experience RAC Certification preferred Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company's clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO's and consultants. Desired Skills and Qualifications · Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job TitleSenior Regulatory Affairs Manager- REMOTE Location(s) US Remote - CT, US Remote - FL, US Remote - GA, US Remote - MA, US Remote - NC, US Remote - NJ, US Remote - VA About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health. Find your future at Revvity Please note: This is a customer-funded position. Continued employment is contingent upon the availability of customer funding. Supports North America Regulatory activities Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements, Develop North America regulatory strategies plan for submission for IVD products Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated Support CE marking activities for IVD products and other market clearance for products manufactured globally Review and approve promotional materials and product labeling Support importation/exportation permitting activities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time. Basic Qualifications: Bachelor's Degree in a STEM field 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) OR Master's or PhD degree in a STEM field 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) Preferred Qualifications: Travel as circumstances dictate Excellent understanding of regulations and guidance documents required in Americas region RAC certified Excellent interpersonal, verbal and written communication skills (in English) Excellent time management, organizational, negotiation, and problem-solving skills Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management Compensation range: The annual base salary range for this full-time position is $140-150,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered. #LI-CH1 What do we offer? We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits: Medical, Dental, and Vision Insurance Options Life and Disability Insurance Paid Time-Off Parental Benefits Compassionate Care Leave 401k with Company Match Employee Stock Purchase Plan Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page. *For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information. Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage. Position Summary: The Manager, Scientific Affairs will be a key player in the Scientific Affairs team as part of the greater Medical Affairs department. They will serve to support integration of scientific discovery and implementation of new product development. This individual will be responsible for evaluating ingredient supplier clinical studies to ensure the scientific rigor and standard required for Thorne innovation. This individual will possess a high level of knowledge in dietary supplement ingredients, sourcing, and utilization. As part of the Scientific Affairs team, they will ensure the transition of scientific and medical claims discovery to the Medical Affairs team for substantiation. This individual will support the collaboration between the greater Research and Development functions of the company and the commercialization teams within Medical Affairs, Sales, and Marketing. Successful candidates for this role will have deep expertise in vetting scientific literature for validity, accuracy, regulatory qualification, and value to company product strategies. This is a remote position. Responsibilities * Integral to the day-to-day activities of the Scientific Affairs team, including ingredient research, literature reviews and dossier development. * Provides support to the greater Scientific Affairs team by coordinating meetings, managing calendars, tracking new ingredient inquiries, supplier communications, and project status. * Assists in the organization and maintenance of Scientific and Medical Affairs templates, scorecards and additional in-house tools. * Prepares and organizes materials for internal presentations and supports ongoing data tracking needs * Independently functions as an integral member of the Scientific Affairs team in creating a pipeline of new ingredients for consideration in new product development and existing product reformulations. * Provides scientific expertise and input in communicating product use to internal stakeholders across departments. * Supports the creation of claims dossier outlines with an organized and efficient handoff to the Medical Affairs team to finalize claims substantiation. * Establishes and maintains an extensive contact and networking system of innovative ingredient suppliers who meet the Company's quality standards in collaboration with the greater R&D team. * Provides flexible support across Scientific and Medical Affairs projects as needed. * Supports the strategy for Thorne to be recognized as a leader in product science, quality and innovation. * Provides strategic oversight regarding industry trends and new developments with the goal of supporting new business and creating strategic plans that drive integration of the offerings of the company. * Participates in and supports new products, services, and business development initiatives that generate potential revenue creation and growth. * Ensures open and proactive communication between Research & Development, Medical Affairs, Sales, Marketing and other company representatives. What You Need * Bachelor's degree required in nutrition, chemistry, biology, or related field; Master's degree or equivalent research experience preferred. * Deep understanding and ability to critically assess scientific literature for accuracy, rigor, and clinical application. * Comprehensive understanding of emerging trends in the dietary supplement marketplace, and how they may relate to promotional and clinical practices. * Candidates with dietary supplement experience from high-quality, science-first companies will be prioritized. * Highly organized, proactive and capable of balancing both scientific detail and administrative execution * High level of nutritional product knowledge and appropriate use in new product development. * Demonstrates ability to develop and deliver upon business objectives. * Ability to build, develop, motivate and manage high-performance teams. * Comfort with and extensive experience interacting with others at all levels within and outside of the Company. What We Offer * Competitive compensation * 100% company-paid medical, dental, and vision insurance coverage for employees * Company-paid short- and long-term disability insurance * Company- paid life insurance * 401k plan with employer matching contributions up to 4% * Gym membership reimbursement * Monthly allowance of Thorne supplements * Paid time off, volunteer time off and holiday leave * Training, professional development, and career growth opportunities Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com. THORNE IS AN EQUAL OPPORTUNITY EMPLOYER #LI-SC1

**NATIONAL LEADERS IN PEDIATRIC CARE** Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with oversight and governance of Regulatory Affairs department and involved in the day-to-day support of the clinical research studies conducted at Children's Hospital Los Angeles (CHLA). Working collaboratively with key stakeholders within CRO, divisions, as well as colleagues across CHLA's research enterprise, this role advocates for the advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies. Ensures compliance with local, state, and federal laws; accreditation, professional and regulatory agency standards, and licensure requirements. **Minimum Qualifications/Work Experience:** Required: + 6 years of experience in clinical research (e.g., research, clinical, interaction with study population, program coordination). + 2 years prior regulatory experience. + Advanced knowledge of Food and Drug Administration (FDA) regulations and International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines governing the protection of human research subjects. Preferred: 1 year experience supervising and managing staff **Education/Licensure/Certification:** Required: + Bachelor's degree in a related field or an equivalent combination of education and experience. Preferred: + Master's degree in a related field. + ACRP/SOCRA (or equivalent) certification. **Pay Scale Information** USD $104,395.00 - USD $178,963.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. CRSO

Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic and tactical regulatory direction for the review and approval of product, pipeline, and disease state communications for its pain assets in the US. This role is critical in ensuring that all promotional and nonpromotional communications meet regulatory requirements and support Vertex's business objectives. The Director will collaborate cross-functionally to develop viable communications and implement processes that drive compliance and business success. Key Duties and Responsibilities: * Serve as a regulatory expert on US statute, regulations, and relevant guidance governing product promotion and related communications, including pipeline and disease state communications for the pain franchise. * Lead the Communications Review Committee (CRC), provide regulatory review support for the Medical Review Committee (MRC), and act as Global Regulatory Affairs Advertising and Promotion (GRAAP) representative on cross-functional teams. * Chair the CRC for assigned products and therapeutic areas, leading discussions among Regulatory, Legal, Medical, Commercial, and other stakeholders to reach consensus. * Assess regulatory context and provide interpretations of applicable guidance, regulations, and precedents, to proposed communications, as well as interpret and manage submission requirements to Health Authorities. * Enhance collaboration across a matrixed organization and maintain constructive relationships with CRC stakeholders. * Provide input for development products with promotional considerations, including contributions to target product profiles and proposed labeling, and ensure product labeling changes are accurately reflected in promotional materials in a timely manner. * Lead cross-functional efforts to develop, update, and streamline procedures and guidelines related to CRC processes. * Monitor and interpret advertising and promotion regulations, FTC and FDA compliance letters, and health authority guidances to support compliant marketing of Vertex products across a variety of communication medium. * Lead training sessions for stakeholders as needed. Knowledge and Skills: * High level of applied knowledge of Health Authority statutes, regulations, guidance, and industry standards related to advertising and promotional communications for prescription drugs, devices, and investigational treatments. * In-depth understanding of clinical study design and statistical analyses necessary to support promotional claims and other communications. * Familiarity with labeling regulations and global promotional review. * Excellent interpersonal, communication (oral and written), project management, and presentation skills. * Ability to lead, influence, resolve conflict, and drive consensus among diverse stakeholders. * Solutions-driven mindset with strong reasoning and risk management skills. * Experience in pharmaceutical industry regulatory advertising/promotion, including managing launch campaigns and interacting with Health Authorities. Education and Experience: * Bachelor's degree in relevant/scientific discipline or a related field * Typically requires 10 years of experience or the equivalent combination of education and experience #LI-EE1 #LI-Remote Pay Range: $182,000 - $272,900 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Career CategoryRegulatoryJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity Live What you will do Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. To lead GRTs within Amgen's GRAAS organization To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions) Ensure consistency of evidence-based global product communication (eg, regulatory submission documents) Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood Lead GRTs and product teams in formal and informal communications with regulatory agencies Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy Represent Amgen Regulatory on external partnership teams at the product level Lead regulatory process improvements and initiatives Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 5 years of regulatory experience in biotech or science OR Master's degree and 8 years of regulatory experience in biotech or science OR Bachelor's degree and 10 years of regulatory experience in biotech or science Preferred Qualifications: Contemporary obesity experience desired Demonstrated ability to lead regulatory aspects of highly complex programs in late development Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application Ability to lead and build effective teams Strong communication skills - both oral and written Ability to understand and communicate scientific/clinical information Ability to anticipate and mitigate against future strategic issues and uncertainties Ability to resolve conflicts and develop a course of action Cultural awareness and sensitivity to achieve global results Planning and organizing abilities Able to prioritize and manage multiple activities Ability to make complex decisions and solve problems Ability to deal with ambiguity Organizational savvy Negotiation skills Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #Obesity . Salary Range 216,805.00 USD - 259,624.00 USD

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Job Description Required: (Remote Opportunity - Temp to Perm) • The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. • In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. • The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. • Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters. Key responsibilities: • Lead Regulatory Associates or Specialists in addition to work as an individual contributor • Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions) • Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. • Develop Regulatory Strategies for new or modified products and prepare project plans & budgets. • Monitor and provide management with impact of changes in the Regulatory environment. • Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. • Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators. • Support Design Control process. • Prepare Rational to file documentation for modifications to devices when appropriate. • Participate in FDA & other notified body Inspections. • Author and/or review regulatory procedures and update as necessary. • Review change control documents and ascertain Regulatory impact for external and internal documents. • Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. • Review promotional material and labeling for regulatory compliance. Qualifications Required qualifications:(Remote Opportunity) • Bachelor's degree required. Scientific or engineering field preferred. • 5+ years of medical device regulatory affairs experience. • Must have authored 510(k) submissions • Must have knowledge of U.S. FDA regulations and standards • 3+ years of experience interacting with FDA and/or other regulatory agencies • Experience with devices containing software is strongly preferred. • Must work well in team environments • Must demonstrate leadership skills in team setting. • Proven analytical abilities • Solid understanding of manufacturing and change control, and an awareness of regulatory trends Additional Information To know more on this position or to schedule an interview, please contact; Ujjwal Mane ************ ujjwal.mane[@]collabera.com