Regulatory affairs director jobs near me - 144 jobs

A leading pharmaceutical company in San Diego is seeking a Regulatory Affairs Manager to oversee regulatory strategies for their development programs. You will work with cross-functional teams to ensure timely submissions and maintain regulatory compliance. The position requires a scientific degree and substantial experience in in relevant regulatory affairs. Benefits include competitive salary and health insurance. #J-18808-Ljbffr

A leading consulting firm in regulatory affairs is seeking a Regulatory Affairs Consultant to work remotely, supporting ongoing projects with 10-20 hours per week. You will lead the development and execution of regulatory strategies, engage with the FDA, and provide guidance throughout product development. The ideal candidate will have an advanced degree in science or biomedical engineering and a minimum of 10 years of experience in regulatory applications. Join a diverse and inclusive team dedicated to impactful work. #J-18808-Ljbffr

A leading healthcare organization is seeking a Market Vice President of Pharmacy Professional Practice to oversee pharmacy compliance across various settings. This role requires a Bachelor's degree in Pharmacy and at least 5 years of relevant experience. The candidate will ensure regulatory compliance and lead a high-performing team. Candidates should possess extensive pharmacy knowledge and significant management experience. This position offers competitive compensation and requires occasional travel for meetings and training. #J-18808-Ljbffr

EXCITED TO GROW YOUR CAREER? WE'RE GLAD YOU'RE HERE!Maritz is seeking a Compliance & Program Manager (HCP Events). This role combines healthcare compliance expertise in event management with planning & event management (planning approximately 15%). Acting as the primary client liaison, you'll ensure adherence to life sciences compliance regulations while overseeing HCP transfer of value reporting, financial accuracy, and operational coordination for assigned events. The position requires balancing regulatory standards with client objectives to deliver exceptional service and flawless execution. What You'll Be Doing 60% - Compliance Oversight & Reporting:Ensure all events comply with HCP (Healthcare Provider) regulations and client-specific compliance guidelines. Maintain and update SOPs, manage HCP documentation templates, and oversee the accuracy of websites and registration platforms (e.g., Cvent). Generate aggregate spend and quality control reports, resolve data issues, and ensure timely and accurate HCP payments and honoraria. 15% - Program Planning & Execution:Lead the end-to-end planning and execution of meetings and events. Manage timelines, budgets, and logistics including venue sourcing, AV, DMCs, air travel, and third-party contracts. Coordinate site inspections, facilitate client working sessions, and ensure internal teams are aligned with program goals. 10% - Financial Management:Oversee program financials including forecasting, tracking, and reconciliation. Manage supplier payments, client invoicing, and change orders. Audit final billing documentation to ensure accuracy and compliance with financial policies. Collaborate with accounting and clients to resolve outstanding items. 10% - Client & Team Communication:Act as the main point of contact for clients and internal stakeholders. Lead status meetings, maintain project documentation, and provide clear direction to project teams. Ensure alignment with client expectations and service level agreements (SLAs). 5% - Special Projects & System Management: Support special projects as assigned. Maintain data integrity within client systems (e.g., Cvent), including contract information, SLAs, and custom fields. Ensure timely and accurate data entry by event managers. What You'll Bring 5+ years of experience in event management, preferably in the life sciences or healthcare sector. Strong knowledge of HCP compliance regulations and aggregate spend reporting Proficiency in event management platforms (e.g., Cvent) Excellent organizational, communication, and financial management skills Ability to manage multiple priorities in a fast-paced environment Things You Should Know This is remote position. Some travel may be required. DISCLAIMER: This job description is designed to indicate the general nature and level of work performed by associates within this classification. It is not designed to confirm or be interpreted as a comprehensive summary of all duties, responsibilities and qualifications required of associates assigned to this job. Maritz offers a comprehensive benefits package for full-time employees including medical, dental, vision, life insurance, disability, 401k, tuition reimbursement, paid time off, and more! Part-time employees may qualify for medical, 401k, and paid time off depending on total hours worked. View all details at *********************** Maritz will only employ applicants who have authorization to work permanently in the U.S. This is not a position for which sponsorship will be provided. Those who need sponsorship for work authorization now or in the future are not eligible for hire. No calls or agencies please. Maritz is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, marital status, political affiliation, sexual orientation, gender identity, genetic information, disability or protected veteran status. We are committed to providing a workplace free of any discrimination or harassment. If you have a disability and are having difficulty accessing or using this website to apply for a position, you can request help by calling or by sending an email to .

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.

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.

The Task At Hand: Shape the rules. Unlock new markets. Drive the future of THC beverages. JuneShine Brands is building an innovative social tonic platform, with Willie's Remedy+ leading the next wave of THC beverages. As one of the fastest-growing brands in the category, we're entering a critical growth phase where regulatory leadership and advocacy will define who wins. As the Director of Regulatory Affairs, you'll serve as our in-house expert on hemp beverage regulation - anticipating where state and federal rules are going, influencing outcomes, and guiding our expansion into new markets. From market access to packaging and DTC considerations, you'll turn regulatory complexity into a competitive advantage. This is a high-impact, externally facing role reporting to the CFO and working closely with the CEO, Board, and industry partners to advance advocacy efforts and unlock scalable growth. If you thrive in ambiguity, enjoy shaping emerging policy, and want to help define a fast-moving category, this role is for you! Who You Are: Strategic regulatory and government affairs leader navigating complex state hemp laws Deep expertise in hemp and cannabis beverage regulations with a business-first mindset Hands-on, entrepreneurial operator comfortable owning regulatory strategy, advocacy and compliance oversight Thrives in ambiguous, rapidly evolving regulatory environments Relationship builder with regulators, policymakers, and industry partners Effective collaborator with leadership, and cross functional teams What You'll Do: Regulatory Strategy & Advocacy: Critical Focus: Anticipate and help shape hemp beverage regulations, with particular emphasis on packaging formats, DTC considerations and market access Represent Willie's in state-level advocacy efforts, industry coalitions and working groups Build and maintain relationships with state regulators, policymakers, and key industry associations Develop and deliver regulatory positions, comments, and advocacy materials to influence outcomes in priority markets Identify and pursue opportunities to proactively influence regulatory direction before rules are finalized Educate external stakeholders on hemp beverage safety, consumer benefits and responsible regulation Hemp State Regulatory Oversight & Market Enablement: Serve as the primary internal expert on state hemp beverage regulations across all active and expansion markets Monitor evolving state regulatory frameworks and advise leadership on business implications and strategic tradeoffs Support market entry and expansion strategies based on state-specific regulatory requirements Partner with internal teams to ensure alignment across formulation, labeling, marketing, and go-to-market execution Stay ahead of enforcement trends through ongoing engagement with state regulatory agencies Compliance Leadership & Team Development: Lead and develop the compliance function as Willie's Remedy+ scales nationally Set compliance strategy, priorities and operating rhythm to support multi-state growth Ensure the team has the resources, guidance, and clarity needed to executive effectively Must Haves: 21 years of age or older at the time of application 5-8+ years of experience in regulatory or government affairs within hemp, cannabis, adult beverage, or other highly regulated CPG categories Deep knowledge of state-level hemp beverage regulations, including market access and packaging considerations Proven experience engaging with or influencing state regulators, policymakers, or industry groups Ability to translate complex regulatory requirements into clear, actionable business guidance Experience partnering with executive leadership to inform strategic and commercial decisions Experience leading or mentoring regulatory or compliance professionals Ability to support key markets (preference for CA, TX, or DC) and travel as needed Nice to Haves: JD or formal legal training Existing relationships with regulators or industry advocacy groups Experience supporting market expansion or retail enablement Familiarity with FDA, TTB, or state beverage control agencies Exposure to DTC or e-commerce in regulated categories Experience building or scaling compliance or regulatory functions within a growing organization Entrepreneurial mindset with comfort operating in fast-moving, ambiguous environments Compensation, Perks + Benefits: Compensation: $150,000 - $160,000 per year The final offer will be based on several factors, including experience, skills, and overall expertise Equity Eligible Perks + Benefits: Unlimited Paid Time Off Healthcare coverage: up to 90% company contribution for employees and 25% for dependents Voluntary vision, dental, and accidental plans 401(k) with up to 4% company match 12 weeks of paid Equal Parental Leave, $500 Baby Bonding Bucks, and a sustainable baby gift Booch, spirit, beer, and soft good perks And more! Who We Are Our Purpose: To make quality, purpose-driven beverages Our Business: Our vision is to create the next-generation beverage platform, comprising distinct brands, each with its own ethos and purpose. Despite being a multi-billion dollar industry, it lacks options that cater to the next generation of drinkers who will demand more from their alcohol than a mere buzz. Disrupting this industry is a worthy, and massive opportunity. Our Culture: Our core values are Quality, Transparency, and Team-First. We derive much of our management policy from a book we give you upon hiring, ‘Let My People Go Surfing', by Yvon Chouinard (founder, owner, Patagonia). Our policy is to allow workers flexible hours, provided the work gets done with no negative impact on others. Our ‘let my people go surfing' policy demands that we hire very unique individuals; those with a combination of self-motivation, self-discipline, and energy. JuneShine Brands is a purpose-driven organization composed of a diverse and dynamic group of individuals with varied backgrounds, passions, and beliefs. We are committed to fostering an inclusive environment where everyone's unique perspectives are valued. We seek to hire self-motivated, independent thinkers, who embrace challenging the status quo. Join us at JuneShine Brands where you're encouraged to bring your authentic self to your craft every day. As a proud equal opportunity employer, we are dedicated to ensuring fairness and equity in our hiring practices. You must reside in the United States to be considered for this position. This role supports multiple beverage brands within the JuneShine Brands portfolio, including alcohol and hemp-derived THC beverages.All Juneshine Brands products are intended for adults 21+. ©2025 Juneshine Brands| ***************** | ******************** | ******************** | Please enjoy responsibly. All rights reserved.

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.

At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team. As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients. Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role. This is a Remote position. Responsibilities include: · Act as the primary Regulatory expert within an assigned client's Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs. · Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned product's lifecycle. · Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate. · Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed. · Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned. Qualifications for this position include: · At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review. · Ability to work independently in a remote role with minimal oversight.· Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities. · Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes. · Bachelor's degree (advanced degree in a science discipline preferred) As a part of our full-time team, you are eligible for our Comprehensive Benefits including: Medical, Dental and Vision Insurance Disability Insurance and Life Insurance 401(k) program with company match A balanced approach to work-life that offers a generous PTO program and Holidays. This is a remote position. Compensation: $170,000.00 - $210,000.00 per year We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. At Canopy, we help companies speed science from pipeline to people with end-to-end expertise and seamless support along the drug development journey. We provide both strategic and tactical solutions in the areas of MLR & Content Solutions, Medical Review, Medical Talent Solutions, Regulatory Affairs, Regulatory Operations, and Veeva Solutions. Together, we partner with our customers to deliver the on-demand expertise, technology, and service to catalyze their progress and get their product to the patients who need it, sooner. Our culture of one of empowerment, everyone in our company has a voice and plays a role in the success of the business and a role in developing our values and behavior. We recruit, train and develop people to ensure the very best for our client partners.

SummaryThis role reports to the Global Head of Regulatory Affairs GE HealthCare's Pharmaceutical Diagnostics (PDx). This role provides strategic regulatory leadership for GE HealthCare's Pharmaceutical Diagnostics (PDx) business across the US and Canada. This role drives regulatory strategy for product development, submissions, approvals, and post-market compliance, ensuring alignment with business objectives and regulatory requirements. Acts as the primary liaison with FDA, Health Canada, and other authorities, influencing outcomes and accelerating time-to-market. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description Key Responsibilities: Regulatory Strategy & Execution Develop and implement regional regulatory strategies to enable timely product approvals and lifecycle management. Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development. Agency Engagement Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries. Represent GE HealthCare PDx in regulatory meetings and industry forums. Cross-Functional Leadership Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies. Support the RA team providing regulatory guidance on labeling, advertising, and promotional materials. Team Leadership Lead and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high-quality deliverables. Foster a culture of compliance, agility, and continuous improvement. Governance & Compliance Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers. Drive initiatives to improve regulatory efficiency and proactively manage compliance risks. Business Support Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements. Support budget planning for the Regulatory Affairs function. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets. Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components. Experience leading meetings with FDA and Health Canada. Background in sterile injectables; radiopharmaceutical experience is a strong asset. Desired Characteristics: Strategic thinker with strong analytical and problem-solving skills. Excellent oral and written communication; ability to influence and negotiate effectively. Proven leadership and team development capabilities. Strong project management and organizational skills; ability to manage complex priorities. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $180,000.00-$270,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: February 09, 2026

The Regulatory Labeling Manager serves as a vital member of the MLR team, providing strategic, science-driven regulatory guidance to cross-functional teams. The role involves offering insights on promotional strategy, claim development, labeling alignment, and risk management. As a key regulatory thought partner, you will enable compliant communication of complex clinical and scientific data across Commercial and Medical leadership. Responsibilities + Serve as the Regulatory representative on the MLR team. + Independently review and approve promotional materials to ensure compliance with FDA regulations, product labeling, guidance documents, and internal policies. + Assess the impact of labeling changes on promotional strategy and ensure timely, compliant updates across all materials. + Support promotion of products in development, including accelerated approval and post-marketing commitment considerations. + Serve as primary liaison with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising & Promotional Labeling Branch (APLB). + Lead regulatory strategy and execution for OPDP submissions, including advisory comments, time-of-first-use submissions, Form 2253 filings, etc. + Monitor FDA enforcement trends, regulatory guidance, and biotech industry best practices; translate insights into internal guidance and training. + Partner closely with Medical Affairs, Clinical Development, Labeling, Legal, and Commercial teams to ensure consistent, accurate, and compliant messaging across channels. + Provide strategic regulatory labeling guidance to cross-functional teams. + Oversee the creation, revision, and maintenance of product labeling, including Core Data sheet, Prescribing Information (USPI), Medication Guides, Patient Package Inserts, and container labeling. + Ensure consistency and alignment between labeling content, clinical data, risk management activities, and promotional messaging. Essential Skills + 8-10+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry. + 5+ years of direct experience in Regulatory Advertising & Promotion. + Demonstrated experience supporting product launches and lifecycle experience with FDA advertising and promotion regulations. + Knowledge of FDA evidence standards for promotional claims, including interpretation of clinical trial data and scientific literature. + Excellent written and verbal communication skills and strong regulatory judgment. + Proficiency with regulatory and document management systems and Microsoft Office tools. Additional Skills & Qualifications + Bachelor's degree in a scientific, healthcare-related, business, or legal discipline. + Advanced scientific degree (MS, MD, PharmD, PhD) preferred. + Experience participating in Label Working Groups and supporting U.S. and global labeling strategies. Work Environment This is a remote, part-time position, offering flexibility and the ability to work from home. Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $90.00 - $150.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jan 28, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

At Sirona Medical, we're building software that enables physicians to work as fast as they can think. Each year in the U.S., billions of patient images are captured-and nearly all of them are reviewed and diagnosed by radiologists. These specialists are the central hub of diagnostic medicine: over 80% of all healthcare data flows through radiology IT systems. Yet despite their pivotal role, radiologists are overburdened by outdated, fragmented software which limits their efficiency and ultimately the quality and efficiency of care that health systems can provide patients. That's where Sirona comes in. We're a San Francisco-based, cloud-native software company with employees around the world. Our deep understanding of both the practice and business of radiology has allowed us to build RadOS-a unified, AI-powered operating system powering the entire radiology workflows. How Sirona Solves the Problem Sirona is uniquely positioned to transform the way radiology is practiced. We're delivering the organizational shift that both individual radiologists and entire practices urgently need: A unified, intuitive, and platform-agnostic solution A streamlined workspace that makes every part of the radiologist's workflow faster and easier The freedom to read from anywhere, for anyone By cutting clicks, optimizing diagnostic time, and unlocking efficiencies that extend far beyond the reading room into all care settings, Sirona empowers radiologists-and in doing so, we help the entire healthcare system move faster, smarter, and with greater impact on patient outcomes. For more information, please visit ******************************** The Regulatory Affairs Manager (“RAM”) at Sirona will help build a comprehensive, global regulatory system, support teams in executing quality and regulatory guidance, identify and resolve regulatory-related issues, and drive continuous improvement. This individual will lead the execution of cross-functional regulatory initiatives and serve as a key representative and partner to the VP of Regulatory Affairs and Quality Assurance. Key Responsibilities: Partner with leadership and product managers to establish medical device classifications. Execute related plans to obtain required regulatory clearances or approvals in a timely manner Leverage external regulatory firms to design regulatory strategies and lead internal execution Determine regulatory requirements for selling and marketing Sirona medical devices globally, including local device classification, registrations, and in-country representation with appropriate partners Host audits and inspections conducted by U.S. and global regulatory agencies or standards bodies Collaborate cross-functionally to ensure regulatory requirements, concepts, processes, and objectives are clearly understood by all stakeholders Manage execution of regulatory affairs plans, including defining progress metrics and implementing escalation processes as needed Define and execute required regulatory certifications and MDSAP plans Host internal audits and regulatory inspections in partnership with the VP of RAQA Work closely with the engineering organization to establish, track, and continuously improve regulatory metrics Develop deeper regulatory and quality expertise through hands-on experience and mentorship Represent the VP of RAQA as needed, exercising sound judgment and decision-making (e.g., managing high-volume inquiries or operational decisions) Maintain a global regulatory watch and advise the business accordingly Key Requirements: 7+ years of medical device regulatory experience, preferably in software or technology-driven environments Working knowledge of FDA medical device regulations (Class I and/or II), EU MDR, and global regulatory standards, including ISO 13485 Strong organizational and communication skills, with the ability to produce clear, concise, and well-maintained documentation Experience conducting internal audits or supporting audit activities Experience hosting audits and regulatory inspections Ability to write, edit, and improve quality and regulatory procedures covering the full product lifecycle from pre-market through post-market Ability to create and deliver training materials for new or updated procedures Demonstrated ability to quickly learn and implement new quality management and regulatory standards A proactive self-starter with a positive, growth-oriented mindset Benefits Stock Options Medical, dental, vision insurance Life insurance Maternity and Paternity Leave Flexible time off 401K matching MacBook Pro Sponsorship for conferences, continuing education, etc. The annual US base salary range for this full-time position is $130,000 - $160,000 + equity + benefits. Pay scale is flexible depending on experience. Within the range, individual pay is determined by work location and additional factors, including job-related skills, competencies, experience, relevant education and training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

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

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: Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and/or products with considerable technical complexity and diversity requiring impact on internal decision making. The assigned area responsibility may be focused on global and/or regional development compounds and new indications / formulations of commercial products and/or life cycle management of commercial products within a within a region. Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early stage of clinical development), or as a regulatory representative for commercial products requiring multifaceted problem solving and internal decision making. Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas' programs meet all applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products. Responsible for interacting with global and regional peers and regulatory management to align Astellas' regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies. Accountable for project-related and marketed product-related communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring impact on decision making; incorporates regulatory environment trends to ensure the projects/products reflect up-to-date regulatory strategies. May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across regions and functions to develop and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues. Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products. Responsibilities and Accountabilities: Regulatory Excellence Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or commercial products and is accountable for the expert review of major deliverables from a regulatory perspective. Leads regulatory development in GRL or regional regulatory lead roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs with considerable complexity requiring impact on internal and external decision making. Applies understanding of regulatory requirements and trends into the development of aligned regulatory strategies. Develops and contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are aligned with Astellas' short and long-term business strategies and goals. Accountable for the preparation and submission of technical documents to regulatory authorities for assigned projects/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, quality, interpretation and regulatory/scientific rigor to drive success with regulatory authorities and builds consistency in the messaging of data globally. Responsible for execution of the regulatory strategy into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development projects and/or commercial products. Assures submissions reflect the best-in-class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications. Collaborates with GRA management to provide oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies. Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a matrix organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks. Provides regulatory expertise for planning, approving regulatory content. Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and contributes to the preparation of recommendations and robust opinions for management in a timely manner. Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues. May provide regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA. Contributes to the strategy for interaction with Health Authorities or business partners for the assigned projects/products. Builds and maintains good relationships with Regulatory Authorities. Organization & People Management Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc). Represents GRA within project/product teams and collaborates with global Astellas stakeholders to affect global strategies and consistency in regulatory messaging.

At Argenta, we're more than a company - we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organisation (CRO/CDMO) dedicated to animal health. Our uniqueness means: We are ambitious, growing and building a ‘one team' culture, guided by our values. We are team players; We are doers; We are customer-centric; We are innovators . We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better. With bases in New Zealand, the US, the UK and Europe, our 650+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together. TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply. Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO Americas division. About the role: Facilitates and supports the regulatory and drug development requirements of external clients and internal projects Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges Creates regulatory solutions to complex issues Provides client accurate expert regulatory advice on animal health product development Represent Argenta in industry associations (e.g. GADA, AHI, SQA) Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications Requirements: Bachelor's degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred 8+ years experience in veterinary regulatory and/or animal drug development Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA Good written and oral communication skills, and ability to work collaboratively within and across teams Results and bottom line oriented Excellent analytical skills and attention to detail Proven influence, negotiation and persuasion skills Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs This position is subject to a DEA background check post offer and at regular intervals. This position is also required to complete a post offer drug test. Both the background and drug test must comply with company standards or offers of employment will be rescinded. You will also be someone who is aligned with our company values of "We are Doers, We are Team Players, We are Innovators, We are Customer-Centric". We pride ourselves on the uniqueness of our development and manufacturing abilities and the skills and qualities of our team. The position is a remote position working out of your home with domestic and occasionally international travel. Due to the nature of being a global organization, there may be times when this role works outside of normal business hours. Those times would be provided to the employee with plenty of notice. Want to know more about Argenta? Visit our website ********************* Equal Opportunity Employer

Job Description 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. 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.

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

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

The Director, Governance, Risk & Compliance leads a team of analysts to build and maintain an effective GRC program at NextGen Healthcare. The ideal candidate will collaborate closely with the rest of the Information Security department, along with Product, R&D, and Engineering teams to define and partner on appropriate security controls across NextGen products and systems, including NextGen SaaS offerings and platforms. This team will also have responsibility for NextGen Healthcare's Security Governance and various regular Certification cycles and partnering with Legal on Information Security related contracts and requirements. Establish IT audit procedures relevant to HITRUST/HIPAA, ISO 27001, SOC 2, and other data protection or privacy-related regulations Provide governance and security oversight around the company's adoption and use of AI, LLMs, and other generative-AI capabilities Evaluate and test the design and operating effectiveness of technical and administrative security controls Maintain and manage the Third-Party Risk Management program and integration with Vendor and Customer related Security obligations, requirements, and contractual agreements Work closely with the CISO to develop and implement strategies for governance and compliance related to corporate-wide security initiatives Design and implement data protection policies, process and procedures to align with HIPAA and Information Security policies, especially for cloud-hosted data environments and customer data handling throughout the development lifecycle Implement and manage an Identity Governance Program to ensure appropriate authorization to key resources, including the development of a Role Based Access Control and Role Review process. Develop training programs and FAQs related to data protection, privacy and secure data handling procedures Provide oversight and guidance for periodic security assessments to ensure compliance with information security policies and established security controls Develop metrics and compliance dashboards to measure progress for security initiatives and communicate team accomplishments and the effectiveness of audited security controls and processes Maintain and mature the Risk Register, Policy Exception Tracking, and Security Dashboard processes, standards, and components Ensure applications, networks, systems, cloud services, people, and process are assessed, monitored and audited in accordance with security controls related to SOC 2, ISO 27001, HITRUST/HIPAA and the corporate Information Security Policy Work closely with cross-functional teams to ensure security controls have been designed effectively and are working as intended Identify control deficiencies and weaknesses and recommending remediation plans for improvements Create, manage and hold staff accountable for corrective action plans (CAPs) Implement a process for continuous improvement of IT controls Work with internal and external resources to conduct and manage an assessment program for compliance requirements, including auditing and monitor privileged access to critical information systems; authentication and authorization processes; change control processes and IT operations processes Work closely with the Engineering teams to automate monitoring and auditing to reduce manual effort required for compliance activities Develop communication plans for executive-level reporting Lead the team in the development and evolution of security roadmaps, embodiment of strategic plans, understanding controls and process gaps, providing architectural vision, and enabling the larger information security team. Hire, grow and retain team members to expand the team and its capabilities within the organization. Perform assessments of security tools, vendors, and solutions to support information security roadmap initiatives Act as an advocate for mentoring and technical career growth in the information security organization Act as a liaison with other internal NextGen teams or driving new capabilities, product investments, and research to fill coverage gaps. Provide assistance and guidance to Sales and Support teams across various customer engagements. Regularly provide key performance and risk indicator metrics for management visibility into the status, health, and maturity of the Information Security Program at NextGen. Education Required: Bachelor's degree in Computer Science, Programming, Engineering, or similar field. Or, any combination of education and experience which would provide the required qualifications for the position. Experience Required: 4+ years of experience in Information Security with an emphasis on IT audit, IT risk management and/or IT compliance. Prior experience with managing a GRC team. Extensive background in information security services and operations and the people, process, and technology components. Significant experience in fulfilling business needs through the development of solutions through well-organized processes. Experience in client-facing discussions with new and existing customers to discuss security controls and implementations. Significant Service Management and or vendor management experience. License/Certification Required: Appropriate certifications a plus. Knowledge, Skills & Abilities: Knowledge of: Knowledge of technical security control environments and compliance frameworks including CSA CCM, ISO 270001 and SOC 2, HITRUST/HIPAA and GDPR. Skill in: Excellent analytical, technical and internal audit skills. Excellent organizational and documentation skills. Strong project management skills highly desired. Ability to: Proven ability to manage priorities & deadlines and to work independently in a highly dynamic and diverse environment with multiple concurrent projects happening simultaneously. The company has reviewed this to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. NextGen Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.