Associate Director, Global Regulatory Affairs Project Management Revolution MedicinesAssociate Director, Global Regulatory Affairs Project ManagementRedwood City, California$186,000–$233,000 / yearDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Senior Program Director, Commercial Regulatory Affairs Apollo Professional SolutionsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAPreferred Education and Experience: Bachelors degree in Life Sciences, Law, Public Policy, Business, or related field; advanced degrees such as JD, MBA, PharmD, MS, PhD preferred . Join a dynamic and innovative organization at the forefront of global healthcare as our Senior Program Director, Commercial Regulatory Affairs.
Senior Program Director, Commercial Regulatory Affairs SGA Inc.Senior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAResponsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
Senior Director, Regulatory Affairs Ardelyx, Inc.Senior Director, Regulatory AffairsNewark, CA$259,000–$317,000 / yearPartner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications. Qualifications: Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience.
Director, Regulatory Affairs California Life CompanyDirector, Regulatory AffairsSouth San Francisco, CA$275,000–$280,000 / yearPosition Responsibilities: Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business partner, and where there are multiple indications. Calico's highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.
Senior Director, Regulatory Affairs CMC Mirum Pharmaceuticals IncSenior Director, Regulatory Affairs CMCFoster City, CA$280,000–$310,000 / yearThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
Regulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
Director, Regulatory Affairs Nova Pneuma, Inc.Director, Regulatory AffairsFremont, CAPart timeManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Associate Director, Regulatory Affairs (on-site) AbbottAssociate Director, Regulatory Affairs (on-site)Alameda, CaliforniaThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
VP Quality & Regulatory Affairs Alexza Pharmaceuticals, Inc.VP Quality & Regulatory AffairsFremont, CAProvide executive oversight of Quality Assurance activities, including but not limited to: Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release. 15+ years of progressive relevant senior regulatory and QA/QC experience, including at least 8 years executive level experience, in the Pharma biotechnology/pharmaceutical industry with direct regulatory affairs experience with drug/device combination products.
Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAILDirector, Regulatory Affairs - Advertising, Promotional and Labeling #4810Sunnyvale, CA$189,000–$271,000 / yearThe Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
Regulatory Affairs Specialist II The Clorox CompanyRegulatory Affairs Specialist IIPleasanton, CA$90,900–$170,100 / yearThis role requires strong cross-functional collaboration, working daily with partners across R&D (e.g., Product Development), Product Safety, Legal, Corporate Quality, Government Affairs, and Consumer Affairs. Work with Consumer Affairs to develop consumer-facing responses, providing regulatory guidance to ensure accuracy, consistency, and appropriate interpretation of product claims, ingredients, and safety information.
Senior Regulatory Affairs Specialist PROCEPT BioRobotics CorporationSenior Regulatory Affairs SpecialistSan Jose, California$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Senior Director, Regulatory Affairs Rems Program Cytokinetics, IncorporatedSenior Director, Regulatory Affairs Rems ProgramSouth San Francisco, CA$263,880–$307,860 / yearReporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution related to Risk Evaluation and Mitigation Strategy (REMS) and providing regulatory compliance oversight for REMS. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteSan Francisco, CARemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Senior Regulatory Affairs Specialist HyperfineSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearHyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations: Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar ConsultingSenior Program Director (Commercial Regulatory Affairs, Fully Remote)South San Francisco, CaliforniaRemoteYou will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ".
Regulatory Affairs Specialist II Thermo Fisher ScientificRegulatory Affairs Specialist IIFremont, CaliforniaWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Senior Director, Regulatory Affairs (Oncology) Exelixis Inc.Senior Director, Regulatory Affairs (Oncology)Alameda, CA$248,000–$352,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience. Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.