Regulatory process manager jobs near me - 57 jobs

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.

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. See Yourself at Telix The Manager, GRA - CMC 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. The Manager RA CMC 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. Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues. Education and Experience: Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred. 7+ years of 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. Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills 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

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives. Key Responsibilities Develop and implement global CMC and device regulatory strategies for assigned program(s) Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions) Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans Identify regulatory risks associated with product development and propose mitigation strategies Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes Archive and maintain regulatory submissions and correspondences in Apogee's regulatory information management system Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth Ideal Candidate Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field Minimum of 10 years of industry experience, with at least 6 years in CMC regulatory for biologics and/or drug-delivery combination products Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred Proven track record of leading cross-functional submission teams and successful regulatory submissions Strong knowledge of global regulatory requirements (FDA, EMA, ICH) Excellent communication, leadership, and project management skills Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment Up to 15 - 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient, and Egoless The anticipated salary range for candidates for this role will be $220,000-$240,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

About Axiom: Axiom is transforming the legal services landscape by delivering innovative solutions ranging from individual secondees to fully integrated project teams that combine top-tier talent with cutting-edge technology. Join our innovative talent community and help drive impactful legal solutions to complex problems in various industries. Job Description: We are seeking a Regulatory Compliance Counsel to join our Financial Services team. This role is ideal for attorneys with hands-on experience in banking regulation, margin lending, and financial products compliance. The position focuses on supporting major financial institutions - primarily onsite in New York - across a range of complex regulatory and remediation projects. We are particularly interested in candidates with documented experience on the new Margin Lending rule, as well as those with equipment financing (industrial) experience and exposure to CFTC, SEC, and FINRA compliance. Responsibilities: Advise financial institutions on compliance with federal and state banking regulations, including margin lending (Reg T, Reg U, and FINRA 4210) requirements. Support regulatory remediation and supervisory projects involving consent orders, enforcement actions, and internal compliance reviews. Provide guidance on swap execution facilities (SEFs), alternative trading systems (ATSs), and direct market access (15c3-5) compliance. Collaborate with client legal, risk, and compliance teams to enhance governance frameworks and implement regulatory best practices. Counsel on equipment financing transactions and related industrial lending regulations. Advise on AML, KYC, and client onboarding frameworks for private market and alternative investment managers. Monitor state-regulated industry developments, including insurance compliance obligations. Qualifications: 2+ years of experience in financial services regulatory compliance, preferably at or advising banking institutions or regulators. Proven background in margin lending compliance and trading infrastructure regulations (CFTC, SEC, FINRA). Experience in regulatory remediation projects or bank supervisory roles (OCC, FRB, FDIC experience highly valued). Strong analytical skills and ability to interpret evolving regulatory guidance. Juris Doctor (JD) and admission to practice in a U.S. jurisdiction. Onsite availability in New York City is required. Preferred Skills: Experience with equipment financing and industrial lending transactions. Background in AML/KYC and private funds client onboarding. Familiarity with insurance compliance and state-by-state regulatory analysis. Demonstrated success in cross-functional regulatory projects Compensation, Benefits & Location: This role offers a range of competitive compensation starting at $170k and a highly competitive benefits package in the alternative legal services marketplace that includes health benefits, 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence. Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today's business landscape with best in breed alternative legal services. Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom's legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Learn more about working at Axiom. Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at ********************* and include “Applicant Accommodation” in the subject line. Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full privacy notice is available at **************************************** Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. By submitting an application, you acknowledge that all information contained therein, and provided at any part of the application process, is correct and accurate to the best of your knowledge. #LI-LC3

WHO WE ARE The Edison Electric Institute (EEI) is the association that represents all U.S. investor-owned electric companies. Our members provide electricity for more than 220 million Americans and operate in all 50 states and the District of Columbia. As a whole, the electric power industry supports more than 7 million jobs in communities across the United States. In addition to our U.S. members, EEI has more than 65 international electric companies, with operations in more than 90 countries, as International Members, and hundreds of industry suppliers and related organizations as Associate Members. EEI employees are required to work in office Monday-Thursday, and have the option to work remotely on Fridays. KEY RESPONSIBILITIES OF THE MANAGER, POLITICAL AFFAIRS: The Manager, Political and External Affairs plays a critical role in advancing EEI s federal political engagement strategy by supporting the Senior Director across three core areas: PAC fundraising, industry event management, and political programming. The Manager serves as the internal lead for PowerPAC fundraising, driving engagement from member companies. The Manager collaborates closely with the PAC Steering Committee and EEI leadership to meet annual fundraising goals, manage the PowerPAC budget, track performance, and ensure full compliance with all reporting requirements. The Manager also produces treasurer s reports, maintains donor and disbursement records, and provides background materials to support contribution decision-making. Other important responsibilities of the Manager, Political Affairs: Support the Senior Director in executing PowerPAC s fundraising strategy, helping to engage all eligible groups and member companies to meet annual fundraising goals. Assist in developing PAC campaigns, strengthening relationships, and identifying opportunities to expand PAC participation and visibility. Assist in managing the PowerPAC budget, including tracking fundraising totals, monitoring financial activity, preparing candidate disbursements, and supporting PAC Steering Committee operations. Prepare treasurer s reports and write detailed memos summarizing political background information, candidate assessments, and related analysis. Play a central role in planning and executing EEI s major political and industry events, ensuring operational excellence and strategic alignment with EEI s advocacy objectives. Provide operational, financial, and compliance support to the Senior Director, including processing invoices; coordinating with the General Counsel s office on contracts; and preparing materials for the semiannual LD-203 contributions report. Administer the charitable PAC match program, ensuring accuracy and timely processing on behalf of EEI employees who contribute to PowerPAC. REQUIRED & PREFERRED QUALIFICATIONS: A bachelor s degree in Political Science, Communications, Public Policy, or a related field is required. 6-8 years of experience in PAC management, political fundraising, political operations, or planning high-level political or industry events is required. Demonstrated ability to research, interpret, and analyze political trends and developments. Exceptional written and verbal communication skills with experience drafting policy briefs, analytical reports, and background materials for senior leaders, elected officials, or policymakers., Strong technical and administrative skills, including proficiency with Office 365 and Microsoft Office applications, and the ability to learn internal accounting and budgeting systems. Strong organizational skills and the ability to take initiative, manage competing priorities, and complete projects in a timely manner are essential. Travel requirement: 10%. COMPENSATION The salary range for role is $80,000-125,000. Starting annual salary will be determined on individual qualifications. We offer a competitive benefits package that includes medical, dental, vision, 401k, paid time off, tuition assistance, wellness incentives and programs, transportation subsidy, and professional development opportunities. The role is eligible for a performance based bonus for the 2026 calendar year which is paid out the following March. PHYSICAL AND SENSORY DEMANDS Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EEI is committed to providing a productive and safe environment. To achieve that goal, we conduct background and reference check investigations for all final applicants being considered for employment. Equal Opportunity Employment M/D/F/V.

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

Business Unit: Global Regulatory Affairs Execution Team Employment Type: Contract Duration: 6+ months (with possible extensions) Rate: $46 - $50 /hr. W2. Posting Date: 6/27/2024. Notes: Only qualified candidates need apply. Fully remote. Approximately 30 hours per week. 3 Key Consulting is hiring! We are recruiting an Regulatory Writing Manager for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Day to day activities include: Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for regulatory documents and regulatory submission strategy Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance Ensure quality of regulatory submission documents at all stages of development Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams Participate in departmental meetings, as well as departmental and cross-departmental initiatives Top Must Have Skill Sets: Must have experience briefing documents with significant clinical content/Module 2 clinical summary documents. Looking for 3-5 years of experience with these document types. Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Basic Qualifications: Doctorate degree Or Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience Or High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience Preferred Qualifications: Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Strong written/oral communication skills and attention to detail Understanding and application of principles, concepts, theories, and standards of scientific/technical field Strong time and project management skills, engaging approach, and perseverance with a drive for results Leadership skills and ability to guide and influence the work of others Strong leadership in a collaborative team environment Why is the Position Open? Supplement additional workload on team Interview Process: Phone screens and video conference We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team

Maserati produces a complete range of unique cars with an amazing personality, immediately recognizable anywhere. With their style, technology and innately exclusive character, they delight the most discerning, demanding tastes and have always been a global automotive industry benchmark. A tradition of successful cars, each of them redefining what makes an Italian sports car in terms of design, performance, comfort, elegance and safety, currently available on more than 70 markets internationally. The role of TSRC Manager will be responsible for overseeing the compliance-related activities concerning the business perimeter of Maserati Americas, in coordination with Maserati HQ, Stellantis N.A. TSRC, S.E. Tech Center, CCLP teams. This Leader will be the Official Maserati representative (with power of attorney) with Agencies & Trade Associations and support in key Maserati governance (e.g. RTM) and coordination/approval meetings. Key Responsibilities Interface with federal, province, and state agencies on regulatory policy and compliance. Support technical committees at the Alliance for Automotive Innovators in U.S. and Global Automakers in Canada in coordination with Stellantis' TSRC. Assemble “Maserati-specific” concerns on major North American rulemakings and coordinate with Stellantis' TSRC on their potential inclusion in formal Stellantis responses Submit all safety related reports to federal, province, and state agencies. Manage safety recall process for US and Canada. Manage new model year CPCR process with Maserati S.p.A. and FCA US TSRC. Review Owner's manual & Warranty Books. Approve Safety, Emissions, and other Homologation Labels for each model year. Manage FMVSS and CMVSS phase in plans in cooperation with Maserati S.p.A. and FCA US TSRC. Oversee, manage, and execute integrated plans for certification of Maserati products (planning & execution phases) Validate certification applications and fleet reporting for submission to agencies In order achieve certification for each model year, work must be done to define emissions test groups, evaporative test groups, durability groups, OBD groups, and Fuel Economy Groups; lead emissions, fuel economy, and OBD certification activities; interface with Maserati engineering to plan and execute emissions certification testing; gather the required information and submit certification applications including emission test results to EPA and CARB; submit OBD certification documents and DDV test results to CARB; support confirmatory testing as required at EPA laboratory; request EPA certificate and CARB executive orders Troubleshooting and escalation for certification & campaigns Assess Regulation to provide recommendations for portfolio, product & development planning Explore opportunities for exemptions, derogations, optimization of phase-in plans Support Maserati commercial & marketing teams in product communication & dealer training Support Maserati SCM on compliance implications linked to product labeling and logistic flows Budgeting for compliance activities and control of administrative obligations, including submitting payment of emission certification fees to EPA and CARB. Prepare and present the annual emissions certification preview to EPA and CARB. Review, approve, and submit to EPA and CARB all emissions related running change and field fix documents Manage activities relating to emissions related parts and defect reporting Serve as the authorized signer for official documents submitted to agencies on behalf of Maserati US LLC Prepare and submit required importation documents for Canada.

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.

About Us OpenFX is on a mission to move money as freely as data, unrestricted by time zones, banking hours, or legacy systems. We are building the infrastructure that will power the next generation of cross-border payment systems for institutions. The team's execution has been exceptional, and we're scaling at a remarkable pace. Our stellar early team comes with experience in companies like J.P. Morgan, Goldman Sachs, FalconX, Paypal, Affirm, Polygon, Kraken, Nium & others. We're backed by Accel, Lightspeed, NfX and other top-tier investors. Role Overview We are seeking a Head of Americas Licensing and Regulatory Affairs to join our dynamic team. The role will be responsible for driving our acquisition of U.S. state money transmitter licenses and subsequent management of those licenses and our relationships with U.S. state regulators, as well as the acquisition of other licenses to support the rapid growth of our business in the U.S., Canada and Latin America. This role is crucial for enabling our global expansion while maintaining regulatory compliance and strong relationships with regulatory authorities. Key Responsibilities: Licensing Acquisition & Maintenance Complete execution of pending US state money transmitter license (MTL) applications: Complete preparation, coordination, and submission of MTL applications across all required US states, managing multiple applications simultaneously through approval Drive scoping and execution of additional license applications in the Americas: Prepare and submit Money Services Business (MSB) registration in Canada, obtain required U.S. crypto/virtual currency licenses, and secure any required licenses across key Latin American markets. Coordinate with external counsel and consultants: Manage relationships with licensing consultants and outside counsel to ensure high-quality, cost-effective support aligned with business needs Manage license maintenance activities: Oversee all post-licensing obligations including renewals, amendments, quarterly/annual reporting, surety bond management, net worth requirements, and permissible investment compliance Regulatory Relations and Compliance Operations Serve as primary regulatory contact: Act as OpenFX's main point of contact with state banking departments, FinCEN, and other US regulators, as well as FINTRAC (Canada) and Latin American financial authorities Build and maintain regulator relationships: Establish positive, proactive relationships with key regulatory bodies, positioning OpenFX as a compliant and transparent operator Manage regulatory inquiries and examinations: Lead preparations for and responses to regulatory examinations, audits, inquiries, and requests for information from state and federal regulators Prepare regulatory submissions: Draft, review, and submit all regulatory filings, notifications, reports, and correspondence with accuracy and within required timelines Prepare and manage regulatory reports and filings: Coordinate with Finance and other internal stakeholders to submit quarterly, semi-annual, and annual financial and operational reports required under various licenses Cross-Functional Collaboration Support market expansion: Work with internal teams to identify regulatory requirements for new markets and develop paths to licensure Maintain policies and procedures: Review and update regulatory policies, procedures, and compliance manuals to reflect current requirements Build and develop the team: As the business scales, recruit and manage licensing and regulatory professionals What we are looking for Required Qualifications 7+ years of experience in regulatory licensing, regulatory affairs, or regulatory compliance within financial services, fintech, or payments companies Proven track record of successfully obtaining and maintaining financial services licenses, particularly US state money transmitter licenses Strong knowledge of US state money transmission regulatory frameworks, including application processes, surety bond requirements, net worth rules, and examination procedures Regulatory filing expertise: Demonstrated experience preparing and submitting regulatory reports, notifications, and responses to regulatory inquiries Regulator relationship experience: Track record of successfully interfacing with state banking departments, FinCEN, and other financial regulators Exceptional project management skills: Ability to manage multiple complex, time-sensitive licensing applications and compliance obligations simultaneously Outstanding written communication skills: Experience drafting regulatory submissions, applications, policies, and correspondence to regulators Meticulous attention to detail: Strong analytical skills with ability to navigate complex regulatory requirements and ensure accuracy in all submissions Collaborative approach: Commitment to teamwork and ability to work effectively with cross-functional teams and external advisors Bachelor's degree required; JD preferred What helps you stand out: Experience in cross-border payments, FX, or crypto industries Experience with crypto/digital asset licensing (e.g., NY BitLicense, state virtual currency licenses) Experience with international licensing (Canada MSB registration, Latin American licenses) Prior work at a high-growth fintech or payments startup managing rapid licensing expansion Existing relationships with state regulators, CSBS, or Money Transmitter Regulators Association (MTRA) Familiarity with RegTech tools and automation for regulatory compliance and reportin What We Offer Competitive salary and benefits package Impact: Own the licensing function at a critical growth stage and directly enable business expansion Growth: Opportunity to build a function and help scale a successful high-growth company Learning: Opportunity to work in a fast-paced startup at the forefront of fintech innovation. Culture: Collaborative team environment with emphasis on personal and professional growth Mission: Help build the future of global financial infrastructure We are committed to building a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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.

Blockchain.com is connecting the world to the future of finance. As the most trusted and fastest-growing global crypto company, it helps millions of people worldwide safely access cryptocurrency. Since its inception in 2011, Blockchain.com has earned the trust of over 90 million wallet holders and more than 40 million verified users, facilitating over $1 trillion in crypto transactions. As the US Regulatory Compliance Manager, you will be the architect and leader of our US regulatory strategy. This is a cornerstone position responsible for navigating the complex federal and state regulatory landscape to enable our continued growth and innovation. You will own the company's licensing roadmap, serve as the primary relationship manager with regulators, and provide strategic guidance that embeds compliance into the fabric of our products and operations. Your work will be critical to securing the company's long-term success and trustworthiness in the market. WHAT YOU WILL DO Regulatory Strategy & Leadership: Develop, implement, and manage the company's comprehensive US regulatory compliance program. Licensing Execution: Spearhead the company's state-by-state licensing strategy, with a primary focus on obtaining and maintaining Money Transmitter Licenses (MTLs). This includes managing applications, renewals, surety bonds, and required reporting across all relevant jurisdictions. Regulatory Engagement: Serve as the primary point of contact and cultivate strong, proactive relationships with federal and state regulators, including FinCEN, OCC, and state banking departments. Manage all regulatory examinations, inquiries, and correspondence. Product Compliance Advisory: Partner directly with Product, Engineering, and Business leadership to provide proactive regulatory guidance on new products and initiatives. Ensure a “compliance-by-design” approach, translating complex regulatory requirements into actionable product specifications. Reporting: Provide regular, clear reporting on the status of the compliance program, risk exposure, and key regulatory developments to the executive team. WHAT YOU WILL NEED 7 years of regulatory compliance experience within the financial services or fintech industry. Demonstrated, hands-on experience with the US Money Transmitter Licensing (MTL) framework, including application, maintenance, and reporting processes. Deep subject matter expertise in BSA/AML, KYC/CIP, and OFAC sanctions programs. Proven ability to interpret and apply complex financial regulations to innovative products and business models. What we'd love to see (Preferred Qualifications): Juris Doctor (J.D.) or a relevant advanced degree (e.g., MBA). Direct experience with cryptocurrency or digital asset compliance programs. Experience in a high-growth technology company environment. Established relationships and direct interaction experience with key state and federal financial regulators. Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or CRCM (Certified Regulatory Compliance Manager). COMPENSATION & PERKS Competitive full-time salary based on experience and meaningful equity in an industry-leading company This is a role based in our Dallas office, with a mandatory in-office presence four days per week. The opportunity to be a key player and build your career at a rapidly expanding, global technology company in an exciting, emerging industry. Performance-based bonuses Apple equipment provided by the company Work from Anywhere Policy: You can work remotely from anywhere in the world for up to 20 days per year. Blockchain is committed to diversity and inclusion in the workplace and is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, religion, color, national origin, gender, gender expression, sex, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, and apprenticeship. Blockchain makes hiring decisions based solely on qualifications, merit, and business needs at the time. You may contact our Data Protection Officer by email at ******************. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

at Moneycorp Welcome to Moneycorp We're delighted you're interested in being a part of Moneycorp. In the last decade, Moneycorp has transformed from a largely domestic, consumer-focused provider of foreign exchange to an end-to-end global payments' ecosystem. With two banking licenses and operations across the entire value chain of the international payments and foreign exchange sectors, we enable businesses, institutions, and individuals to thrive beyond borders. We help our clients realise their growth ambitions by providing them with worldwide reach, relentless regulatory excellence, and tailored, relevant solutions that resiliently optimise their financial operations. We're fervent about pursuing our goals, making substantial contributions to the payments industry, and consistently offering unwavering support to our clients at every stage of their journey. Moneycorp is a place where energy, commitment to our shared success and collaboration are core to our DNA. We're restless in our drive to surpass the expectations of our clients and unlock opportunities to support them at every stage of their journey. The foundation of our success is our people, and nurturing a culture of belonging for all of our colleagues is central to our journey as a global business. Find out more about Moneycorp's offering, global footprint and capabilities here: About Us | moneycorp Who You Are / Your Next Challenge Moneycorp in Dublin have an exciting opportunity for an EMI (Electronic Money Institution) Regulatory Compliance Manager. The successful candidate will be responsible for supporting the Head of Compliance to ensure effective compliance frameworks are in place which aims to ensure compliance with regulatory requirements and with the conditions of the firm's regulatory authorisations. What we're looking for / Skills that will help you in the role Critical experience required: Experience working in payments/electronic money regulated firms Extensive knowledge and understanding of the applicable EU and CBI regulations Experience/knowledge of outsourcing and operational resilience regulations is required Knowledge and/or experience of DORA would be advantageous Critical skills required: Strong management skills Excellent communication skills, both written and oral Demonstrable track record in regulatory relationship management and compliance framework development Organisational and prioritisation skills Hard working, conscientious and trustworthy Accepts accountability for delivering results against deadlines Problem solver This position is full-time, permanent. The role is expected to be office-based in Dublin, Ireland. What you get in return:This role offers a competitive salary with bonus, plus a comprehensive benefits package. Interested?If the role sounds like you, we invite you to upload a copy of your CV by clicking on the Apply button. Start Date: ASAP Fostering a culture of belonging and inclusivity We're committed to creating a workplace where every individual feels valued, respected, and included. As an Equal Opportunity Employer, we actively cultivate an inclusive culture where diversity thrives, and we empower our colleagues to drive meaningful change within our organisation through initiatives like our DE&I focus groups and value champion network. Like many of our peers, we recognise that fostering inclusivity is an ongoing journey, and we remain steadfast in our commitment to progress. By measuring our efforts through regular assessments and listening to the feedback of our employees, we strive to ensure that our initiatives are impactful and responsive to the evolving needs of our workforce.Together, we want to build a workplace where everyone can bring their authentic selves to work, as we believe this is the foundation of innovation, creativity, and collective success. Connect with us For company news, announcements and market insights, visit our News Hub. You can also find Moneycorp on Facebook, Twitter UK, Twitter Americas, Instagram, LinkedIn, where you can discover how we are leading the way in global payments and currency risk management.

Maserati produces a complete range of unique cars with an amazing personality, immediately recognizable anywhere. With their style, technology and innately exclusive character, they delight the most discerning, demanding tastes and have always been a global automotive industry benchmark. A tradition of successful cars, each of them redefining what makes an Italian sports car in terms of design, performance, comfort, elegance and safety, currently available on more than 70 markets internationally. The role of TSRC Manager will be responsible for overseeing the compliance-related activities concerning the business perimeter of Maserati Americas, in coordination with Maserati HQ, Stellantis N.A. TSRC, S.E. Tech Center, CCLP teams. This Leader will be the Official Maserati representative (with power of attorney) with Agencies & Trade Associations and support in key Maserati governance (e.g. RTM) and coordination/approval meetings. Key Responsibilities Interface with federal, province, and state agencies on regulatory policy and compliance. Support technical committees at the Alliance for Automotive Innovators in U.S. and Global Automakers in Canada in coordination with Stellantis' TSRC. Assemble “Maserati-specific” concerns on major North American rulemakings and coordinate with Stellantis' TSRC on their potential inclusion in formal Stellantis responses Submit all safety related reports to federal, province, and state agencies. Manage safety recall process for US and Canada. Manage new model year CPCR process with Maserati S.p.A. and FCA US TSRC. Review Owner's manual & Warranty Books. Approve Safety, Emissions, and other Homologation Labels for each model year. Manage FMVSS and CMVSS phase in plans in cooperation with Maserati S.p.A. and FCA US TSRC. Oversee, manage, and execute integrated plans for certification of Maserati products (planning & execution phases) Validate certification applications and fleet reporting for submission to agencies In order achieve certification for each model year, work must be done to define emissions test groups, evaporative test groups, durability groups, OBD groups, and Fuel Economy Groups; lead emissions, fuel economy, and OBD certification activities; interface with Maserati engineering to plan and execute emissions certification testing; gather the required information and submit certification applications including emission test results to EPA and CARB; submit OBD certification documents and DDV test results to CARB; support confirmatory testing as required at EPA laboratory; request EPA certificate and CARB executive orders Troubleshooting and escalation for certification & campaigns Assess Regulation to provide recommendations for portfolio, product & development planning Explore opportunities for exemptions, derogations, optimization of phase-in plans Support Maserati commercial & marketing teams in product communication & dealer training Support Maserati SCM on compliance implications linked to product labeling and logistic flows Budgeting for compliance activities and control of administrative obligations, including submitting payment of emission certification fees to EPA and CARB. Prepare and present the annual emissions certification preview to EPA and CARB. Review, approve, and submit to EPA and CARB all emissions related running change and field fix documents Manage activities relating to emissions related parts and defect reporting Serve as the authorized signer for official documents submitted to agencies on behalf of Maserati US LLC Prepare and submit required importation documents for Canada.

Redwood is localizing a global battery supply chain that seamlessly integrates recovery, reuse, and recycling - keeping critical minerals in circulation and driving the energy transition. Founded in 2019, we're delivering low-cost and large-scale energy storage and producing battery materials in the U.S. for the first time, all from batteries we already have. Director, Federal Affairs Redwood Materials is seeking a Director of Federal Affairs, to lead our engagement with the U.S. government, federal agencies, and the Administration on issues central to building a domestic critical materials supply chain and advancing America's energy dominance. In this role, you will shape and execute Redwood's federal strategy across legislative, regulatory, and executive branches-driving policies that strengthen U.S. energy storage, critical materials, and manufacturing competitiveness. You'll work closely with senior leadership to identify and pursue opportunities that advance Redwood's priorities through engagement with the White House, Congress, and key agencies such as the Department of Energy, Department of Defense, and Treasury. This is a high-impact, cross-functional position requiring exceptional strategic judgment, policy fluency, and relationship management. The ideal candidate brings deep experience navigating federal processes, translating complex technical and business objectives into actionable policy goals, and building coalitions to achieve them. This position will be based in Washington D.C. Responsibilities will include: Lead development and execution of Redwood's federal policy and advocacy strategy across legislative, regulatory, and executive arenas. Analyze federal legislation, rulemakings, and policy trends to identify risks and opportunities; develop and implement strategic action plans that advance organizational priorities. Serve as a trusted advocate and representative for Redwood before Congress, federal agencies, trade associations, and policy coalitions. Cultivate and sustain strong relationships with members of Congress, agency officials, the Administration and key energy and critical minerals stakeholders. Coordinate closely with internal teams to ensure policy alignment and cohesive external messaging. Advise and brief executive leadership on policy, strategy, and stakeholder engagement; prepare leadership for high-level meetings and testimony. Desired Qualifications: 10+ years of federal government relations experience required, preferably within the critical minerals or energy sectors. Demonstrated ability to build and maintain trusted relationships across Congress, the Administration, key agencies and the industry. Deep understanding of U.S. energy, manufacturing, and critical minerals policy. Proven success shaping or influencing federal policy outcomes and leading high-stakes advocacy campaigns. Strong analytical and strategic thinking skills, with the ability to translate complex technical and business information into compelling policy positions. Exceptional written and verbal communication skills, adept at briefing executives and conveying complex policy issues clearly and persuasively. Ability to travel as needed. A genuine passion for energy innovation and advancing America's industrial leadership. Physical Requirements: Ability to work at a computer for extended periods (up to 8 hours/day) Occasional lifting of office supplies or documents (up to 20 lbs.) Ability to participate in in-person meetings and travel as needed Working Conditions: On-site work preferred with some flexibility Fast-paced, collaborative team setting with cross-functional interactions Occasional extended hours during peak procurement cycles or project deadline Occasional to frequent travel for meetings, site visits, or events The position is full-time. Compensation will be commensurate with experience. We collect personal information (PI) from you in connection with your application for employment with Redwood Materials, including the following categories of PI: identifiers, personal records, professional or employment information, and inferences drawn from your PI. We collect your PI for our purposes, including performing services and operations related to your potential employment. If you have additional privacy-related questions, please contact us at privacy@redwoodmaterials.com.

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

What will you be doing: The Manager works collaboratively within a team of highly qualified Advisory consultants to deliver performance improvement to healthcare systems. This position will be primarily responsible for performing billable work for clients. The role of the Manager is to actively lead and manage a significant workstream or project. Responsibilities include determining client needs in terms of the engagement statement of work; lead, guide, complete and provide quality assurance over data analyses; interpret data analyses and form initial recommendations; develop final recommendations and solutions for client consideration; develop deliverables and presentations materials for various audiences; assist in the implementation of recommended improvements; assist and manage risk and issues with project leadership; manage project or workstream economics and project administrative activities and logistics. The Manager participates and oversees all aspects of the workstream, or project assigned. They are responsible for the day-to-day management of all activities and staff assigned to their workstream or project. The Manager works in a team environment to provide input, guidance, and quality assurance to team deliverables and presentations during each phase of a project. The Manager will provide mentorship and guidance to all staff working with them on projects. The Manager is responsible for building strong, referenceable client relationships. The Manager is required to also participate in Premier internal activities including practice development, required, and approved educational opportunities throughout the year and learning the various technologies Premier offers to its clients. Additionally, the Manager should: • Maintain utilization targets for client billable projects • Create value through meaningful client relationship management, solution development and implementation delivery • Create a positive team environment by enriching staff skills and knowledge and creating a productive and collaborative environment • Create value for the Advisory practice through meaningful participation in practice related activities aimed at growing and enriching the Practice as a whole or individual Service Lines within the Practice Key Responsibilities Responsibility #1- 60% • Execute/direct/oversee data analyses, initiate interpretations, and conclusions, and prepare verbal and graphic presentations, using methods that are professionally sound and efficient relative to project objectives and conform to standards. Perform quality assurance on project deliverables. • Assist in determining client needs by effectively leading client interviews and utilizing various tools and analytical methods. Summarize analytical findings in a coherent manner and draws insight from observations, interviews, and data analyses. Develops accurate conclusions from findings. Draft's recommendations and potential solutions for team leadership review. Develops final recommendations and solutions for client review. • Effectively execute on project plans in accordance with engagement statements of work and to client satisfaction. • Develop presentations and deliverables for client audiences that communicate strategy and outcomes. • Generate billings revenue by conducting assigned analyses, write and prepare reports, and assist clients in implementing desired changes. • Guide and lead project management related activities for assigned projects. • Manage the budget and expenses for their assigned projects and manage project profitability. • Manage staff assigned to their projects including providing mentoring and education for staff. • Participate in risk and issue identification and mitigation along with the project leadership team. Responsibility #2 - 15% • Participate in practice development activities for the Advisory Services Practice overall or for the Service Lines within the Practice. Responsibility #3 - 10% Learn Premier based technologies and services. Responsibility #4 - 10% • Actively listen for market opportunities on current engagements and collaborative networks and communicates potential leads to managers. • Contribute to the development of sales presentation deliverables using prescribed formats and technology; proactively seeks out opportunities to participate. • Identifies opportunities to improve profitability Responsibility #5 - 5% Complete all required training requirements on an annual basis. Required Qualifications Work Experience: Years of Applicable Experience - 5 or more years Education: Bachelors (Required) Preferred Qualifications Skills: • Coordinate and deliver effective presentations (verbal and written) to client audiences to communicate project outcomes, recommendations, and strategy • Ability to conduct analyses, oversee, and mentor others in the delivery and production of client deliverables • Ability to relate to clients and team members in an effective and collaborative manner • Ability to lead work groups to successful outcomes Experience: • Experience in Health Systems Finance, Operations (clinical, support or operations), Operational or Strategic Consulting, Strategic Planning or Decision Support Analytics • Experience leading cross-functional teams Education: Master's Degree; RN license or other professional license in clinical area of expertise; PMP/Lean Certification This is a remote position and requires up to 75% travel. Additional Job Requirements: Remain in a stationary position for prolonged periods of time Be adaptive and change priorities quickly; meet deadlines Attention to detail Operate computer programs and software Ability to communicate effectively with audiences in person and in electronic formats. Day-to-day contact with others (co-workers and/or the public) Making independent decisions Ability to work in a collaborative business environment in close quarters with peers and varying interruptions Working Conditions: Remote Travel Requirements: Travel 61-80% within the US Physical Demands: Sedentary: Exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves remaining stationary most of the time. Jobs are sedentary if movement is required only occasionally, and all other sedentary criteria are met. Premier's compensation philosophy is to ensure that compensation is reasonable, equitable, and competitive in order to attract and retain talented and highly skilled employees. Premier's internal salary range for this role is $113,000 - $188,000. Final salary is dependent upon several market factors including, but not limited to, departmental budgets, internal equity, education, unique skills/experience, and geographic location. Premier utilizes a wide-range salary structure to allow base salary flexibility within our ranges. Employees also receive access to the following benefits: · Health, dental, vision, life and disability insurance · 401k retirement program · Paid time off · Participation in Premier's employee incentive plans · Tuition reimbursement and professional development opportunities Premier at a glance: Ranked #1 on Charlotte's Healthiest Employers list for 2019, 2020, 2022, and 2023 and 21st Healthiest Employer in America (2023) Named one of the World's Most Ethical Companies by Ethisphere Institute for the 16th year in a row Modern Healthcare Best in Business Awards: Consultant - Healthcare Management (2024) The only company to be recognized by KLAS twice for Overall Healthcare Management Consulting For a listing of all of our awards, please visit the Awards and Recognition section on our company website. Employees receive: Perks and discounts Access to on-site and online exercise classes Premier is looking for smart, agile individuals like you to help us transform the healthcare industry. Here you will find critical thinkers who have the freedom to make an impact. Colleagues who share your thirst to learn more and do things better. Teammates committed to improving the health of a nation. See why incredible challenges require incredible people. Premier is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to unlawful discrimination because of their age, race, color, religion, national origin, ancestry, citizenship status, sex, sexual orientation, gender identity, gender expression, marital status, familial status, pregnancy status, genetic information, status as a victim of domestic violence, covered military or protected veteran status (e.g., status as a Vietnam Era veteran, disabled veteran, special disabled veteran, Armed Forces Serviced Medal veteran, recently separated veteran, or other protected veteran) disability, or any other applicable federal, state or local protected class, trait or status or that of persons with whom an applicant associates. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. In addition, as a federal contractor, Premier complies with government regulations, including affirmative action responsibilities, where they apply. EEO / AA / Disabled / Protected Veteran Employer. Premier also provides reasonable accommodations to qualified individuals with a disability or those who have a sincerely held religious belief. If you need assistance in the application process, please reply to diversity_and_accommodations@premierinc.com or contact Premier Recruiting at ************. Information collected and processed as part of any job application you choose to submit to Premier is subject to Premier's .

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.

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