CMC Regulatory Affairs Director - Lead, Global
$220k - $270kORIC Pharmaceuticals
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. This role requires collaboration across various departments to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary range is $220,000–$270,000 for Director and $250,000–$300,000 for Senior Director candidates. #J-18808-Ljbffr ORIC Pharmaceuticals
- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular... ...experience with FDA, EMA, and ICH guidelines, plus a track record of successful global #J-18808-Ljbffr Socket.devSuggested
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...Suggested
- ...Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs.... ...teams to develop regulatory strategies and prepare global submissions. The role requires strong scientific...Suggested
- Corvus Pharmaceuticals, Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through NDA/MAA and lifecycle management. Reporting to the VP of Regulatory Affairs, the...Suggested
- Scorpion Therapeutics is seeking a Director, Regulatory CMC to lead global CMC strategies across clinical development, approvals, and lifecycle management... ...regions. The role requires ~10 years in CMC Regulatory Affairs with leadership experience, a life-science degree, and...Suggested
- ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through commercialization. You will advance development, regulatory submissions, and lifecycle management across key regions...
- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in South San Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams...
- Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You will coordinate global submissions, interact with agencies, and guide cross-functional teams in a fast-paced environment in South San...
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product...
- Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial products. The role requires deep CMC expertise across small molecules and biologics, exceptional negotiation with authorities,...
$240.94k - $291.96k
...onsite requirements. Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging... ...., PharmD, MS, or BS Significant experience in regulatory affairs (e.g. > 4-7 years) Qualifications Proven success in delivering...Local area$211k - $264k
...mutations in the RAS signaling pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution... ...across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial. The...Full timeWork experience placementLocal area$244k - $305k
...pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global... ...Clinical Development, Biometrics, and CMC to deliver high-quality global submissions... ...12+ years of regulatory affairs experience within the biotechnology...Full timeLocal area- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess... ...-in-class therapies and ensuring clear communication with global health authorities. The candidate should be self-motivated...
- A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive... ...role involves overseeing global Health Authority interactions... ...experience in regulatory affairs, strong strategic skills, and...
- ...Francisco (UCSF) seeks a Senior Regulatory/CMC professional to provide strategic... ...with FDA/EMA guidelines across global operations. Responsibilities include leading cross-functional teams, overseeing... ...coordinating with Regulatory Affairs to address agency questions, ensuring...
- Corvus Pharmaceuticals, a clinical-stage biopharma company, seeks a Director of Regulatory Affairs CMC to develop global CMC strategies for small molecules and lead regulatory submissions. This role partners with CMC, Technical Operations, Quality, and Clinical teams to...
$275k - $280k
...to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative... ...medical breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of...- ...Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory... ...across the US and global markets. The role... ...Director of Regulatory Affairs and will own CMC submissions... .... The candidate will lead CMC strategy, manage regulatory...Work at office2 days per week
- ...Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role... ...Executive Director of Regulatory Affairs and requires strong strategic...Full time
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities... ...scientific degree with 10+ years in regulatory affairs, strong FDA/EMA/ICH knowledge, and...
- Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define and execute the global regulatory strategy for CAR‑T programs from... ...(FDA, EMA), ensuring alignment with clinical, CMC, and development plans. You will lead cross‑functional...
- ...Pharmaceuticals Inc. in South San Francisco is seeking an Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-functional execution,... ..., and ability to navigate complex programs across regulatory and commercial #J-18808-Ljbffr ORIC Pharmaceuticals...
$258k - $320k
...in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage... ...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological...Work at officeWorldwideRelocation package$245k - $285k
...Description The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading... ...activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all...Contract work- Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team in Brisbane, CA. This global lead role develops regulatory strategy for immunology and inflammation, guiding early development and lifecycle management, with...
$275k - $280k
...and happier lives! About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate clinical... ...years focused specifically on CMC Regulatory Affairs. A successful history of contributing to least...Local areaRelocationRelocation package3 days per week$248k - $310k
...preventable, curable and no longer the leading cause of death in the world. It... ...day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To: Head of CMC Regulatory... ...programs to ensure on-time delivery of global, high-quality submissions across...- Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define, develop, and execute global regulatory strategies for CAR-T programs... ...health authorities (FDA, EMA) and collaborate with CMC, Clinical Development, Translational Medicine, and...
- Scorpion Therapeutics is seeking an senior Regulatory Affairs leader to shape global regulatory strategies for immunology and inflammation programs. You will work with Regulatory leadership, development teams, and CROs to deliver robust development plans and submissions...
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