Global CMC Regulatory Director - Biologics & Small Molecules
Meet Life Sciences
Meet Life Sciences in the United States is seeking a Director of Regulatory CMC to lead global regulatory strategies for clinical and commercial products, spanning small molecules and biologics. This role requires deep scientific fluency, meticulous attention to detail, and adept negotiation with global authorities. You will define data packages, draft CMC sections for CTD filings, and manage Modules 3 and 2.3 lifecycle while collaborating with internal teams and remaining current on evolving #J-18808-Ljbffr Meet Life Sciences
- A leading biopharmaceutical company in South San Francisco seeks a Director of Regulatory CMC. This pivotal role involves developing global regulatory strategies for a pipeline of small molecules and monoclonal antibodies, ensuring compliance throughout the product lifecycle...Suggested
- Corvus Pharmaceutical in San Francisco, CA, seeks a Director of Regulatory Affairs CMC to lead global CMC regulatory strategies for clinical-stage... ...pharma regulatory affairs, with strong experience in small molecules, IND/CTA and NDA/MAA processes, and a deep understanding...Suggested
$302.01k - $390.83k
...Description JOB DESCRIPTION Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives. Lead... ...and cultural evolution of the Small Molecules organization while promoting...SuggestedFull timeFor contractorsLocal area$275k - $280k
...increase our understanding of the biology that controls human aging.... ...breakthroughs. Position Description The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to...Suggested$275k - $280k
...and happier lives! About the Job: The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate... ...scientific fluency spanning across both small molecules and biologics, meticulous attention to detail, and the...SuggestedLocal areaRelocationRelocation package3 days per week- Revolution Medicines in San Francisco is looking for an Associate Director, CMC Regulatory to lead the execution of regulatory strategies for clinical... ...collaboration with various teams to ensure compliance with global regulatory requirements. The ideal candidate will bring...
$220k - $270k
Senior Director / Director, CMC Regulatory Affairs 15 hours ago Be among the first 25 applicants Company... ...regulatory strategies in compliance with global regulatory requirements for the... ...skills with a strong background in small molecules, ideally solid‑oral dose...Full timeCurrently hiring$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for drug approvals and submissions... ...or pharmaceutical industry and be adept at managing complex global submissions. The position is hybrid, with remote work and...Remote job$294.1k - $363.3k
...need it most The Executive Director, CMC QA will provide strategic,... ...programs inclusive of biologics, small molecule, gene therapy, and ASO. This... ...Development, Supply Chain, Regulatory, and Quality stakeholders,... ...ICH, and other applicable global regulatory requirements,...Full timeContract workWork at officeLocal areaFlexible hours2 days per week3 days per week$244k - $305k
Revolution Medicines is seeking a Senior Director, Global CMC Lead to provide cross-functional... ...drive integrated CMC strategies for small molecule programs in oncology. The ideal candidate... ...experience in CMC activities and regulatory submissions. This role involves collaborating...- ...patients while transforming your career. Director - PKDM - Small Molecule Portfolio Strategy & Leadership What... ...through clinical development and regulatory submission. You will combine deep... ...including INDs, NDAs, and interactions with global health authorities. Define and...Flexible hours
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and excellent technical writing skills...$244k - $305k
...oriented leader for the role of Senior Director, Global CMC Lead. The Senior Director, Global CMC... ...development‑stage and late‑stage small molecule programs. This individual will partner... ...closely with CMC cross‑functional teams, Regulatory, Quality, Clinical Development, and...Full timeLocal area$200k - $235k
...Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs CMC will serve as a key member... ...and executing global Chemistry, Manufacturing... ...Experience supporting biologics is required; gene/cell... ...operate effectively in a small, fast‑paced biotech environment...$186k - $233k
...seek a strategic and hands‑on Associate Director, CMC Regulatory who will be responsible for executing... ...submissions to support RevMed’s global clinical trials, market applications... ...knowledge in CMC development of NCEs (small molecules) or equivalent. Demonstrated experience...Work experience placement$195.5k - $272.5k
...motivated, self‑driven and enthusiastic Director of Regulatory CMC accountable for ensuring all... ...conventional paradigms and influence global Health Authorities. We are looking... ...late stage and/or commercial large molecules (biologics) is required; experience with combination...Full timeWork at officeWork visa3 days per week$195.5k - $272.5k
...Biotechnology in San Francisco is looking for a highly motivated Director of Regulatory CMC to ensure regulatory compliance for clinical development... .... This position requires a strong understanding of global regulatory guidelines, and the ability to effectively present...- Amgen Inc. (IR) is seeking a Director for PKDM to lead small molecule portfolio strategy and development. This role involves driving the advancement... ...small molecule programs, with responsibilities including regulatory submissions and collaborative project leadership. The...
- Amgen is seeking a Director for the PKDM - Small Molecule Portfolio Strategy & Leadership role in South San Francisco, California. This vital position... ...of small molecule programs from discovery through to regulatory submission, requiring significant experience in Pharmaceuticals...Worldwide
$261k - $322k
..., Inc. in South San Francisco is seeking an experienced Intellectual Property Attorney to manage the company's IP function for small molecule products. This role involves reporting to the VP of Intellectual Property and requires onsite work four days a week. The ideal...- Initial Therapeutics, Inc. is looking for a Director for PKDM leadership in small molecule portfolio strategy. The ideal candidate will lead cross-functional... ...teams, driving innovations in drug development and regulatory submissions, while recruiting and mentoring talent in...
$230k - $270k
...Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of... ...for developing and executing global Chemistry, Manufacturing, and Controls... ...strategies for clinical-stage small molecule programs. This individual will...$218.06k - $327.09k
...Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the... ...of the global regulatory strategy... ...emerging markets, RA CMC, Labeling and... ...experience of overall drug/biologic development... ...Experience in Oncology (small molecules & biologics) is...Hourly payTemporary workWorldwideFlexible hours3 days per week$294.1k - $363.3k
...it most The Executive Director, CMC QA will provide strategic,... ...Ultragenyx programs inclusive of biologics, small molecule, gene therapy, and ASO.... ..., Supply Chain, Regulatory, and Quality stakeholders,... ...ICH, and other applicable global regulatory requirements, Ultragenyx...Full timeContract workWork at officeLocal areaFlexible hours2 days per week3 days per week- Vir Biotechnology, Inc. is seeking a highly motivated Director of Regulatory CMC to lead global regulatory strategy for clinical development and commercialization across multiple modalities. You will collaborate with Technical Operations and Regulatory Affairs to plan and...Work at office3 days per week
- ...partnering with a well-established global pharmaceutical and... ...organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory... ...will report directly to the Director of Regulatory Affairs and... ...discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences,...
- ...San Francisco, CA seeks an Executive Director, CMC QA to provide strategic and operational quality leadership across biologics, small molecules, gene therapies, and external manufacturing... ...team of 8-12 QA professionals, ensure regulatory readiness, drive risk-based oversight...
- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing... ...Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology or related). Preferred advanced...Temporary work
- ...Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is... ...: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred...Temporary workWorldwide
- Allergan is seeking a Director of Regulatory Affairs to lead global regulatory strategies in South San Francisco. This role involves managing the Global Regulatory Product Team, ensuring compliance with regulatory requirements, and actively participating in strategic negotiations...
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