Meet Life Sciences
Associate Director Regulatory Affairs CMC
Meet Life Sciences, San Francisco, California, United States, 94199
Associate Director Regulatory Affairs CMCAssociate Director Regulatory Affairs CMC 1 day ago Be among the first 25 applicants
Check out the role overview below If you are confident you have got the right skills and experience, apply today. This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $190,000.00/yr - $240,000.00/yr Additional compensation types Annual Bonus and Stock options Direct message the job poster from Meet Life Sciences Associate Director / Director, Regulatory Affairs – CMC Bay Area, CA | Hybrid (3 days onsite per week) We are partnering with a rapidly growing, pre-IPO biotechnology company advancing first-in-class therapies in oncology and autoimmune diseases. The team is looking for an experienced
Associate Director / Director of Regulatory Affairs – CMC
to play a critical role in shaping and executing regulatory strategies across early-stage programs. This is an opportunity to join a collaborative biotech environment where you’ll work closely with senior leadership, contribute to the development of regulatory plans, and drive cross-functional alignment on CMC and broader regulatory strategies. Key Responsibilities Provide strategic and operational regulatory input, partnering closely with cross-functional teams to ensure alignment on CMC and overall development plans. Contribute to global regulatory strategies, including pre-IND/IND/CTA submissions, risk assessments, and mitigation planning. Lead early-stage regulatory activities with a strong focus on CMC-related aspects while also acting as a regulatory generalist across nonclinical and clinical. Serve as the regulatory representative on project teams, offering guidance, solutions, and support to enable timely development milestones. Draft, review, and finalize regulatory submissions (IND/CTA, NDA/BLA/MAA), ensuring compliance with global health authority requirements. Oversee regulatory input on manufacturing process changes, change control, and global filings. Lead the preparation of responses to regulatory authority queries and participate in meetings with FDA and other global agencies. Stay current on evolving regulatory requirements and communicate updates across internal teams. Qualifications Degree in life sciences, chemistry, chemical engineering, or a related discipline (advanced degree preferred). 8-10+ years of regulatory affairs experience in the biotech/pharma industry, ideally within a dynamic, fast-paced company
(preferably biologics, open to small molecule) Strong track record of successful regulatory submissions and product approvals, with expertise in FDA, ICH, and EMA requirements (UK/EU experience a plus). Exceptional communication, leadership, and interpersonal skills with the ability to engage across all levels of the organization. Apply for full company information and job description! Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionResearch, Science, and Management IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Meet Life Sciences by 2x Get notified about new Director of Regulatory Affairs jobs in
San Francisco Bay Area . Director/Senior Director, Regulatory Affairs StrategyDirector, Regulatory Affairs - Job ID: 1702Executive Director, Regulatory Affairs CMCVice President / Head of Regulatory Affairs San Francisco County, CA $250,000.00-$275,000.00 3 weeks ago Senior Director, Regulatory Affairs - Job ID: 1668 San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702Senior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 5 days ago Transparency and Regulatory Affairs Director Cotati, CA $153,094.00-$169,209.00 1 week ago Foster City, CA $210,000.00-$225,000.00 6 days ago San Francisco Bay Area $180,000.00-$225,000.00 2 weeks ago South San Francisco, CA $196,000.00-$240,000.00 6 days ago Associate Director Regulatory Affairs - Global Regulatory ServicesAssociate Director/Director Regulatory Affairs San Francisco Bay Area $190,000.00-$250,000.00 15 hours ago San Carlos, CA $170,000.00-$220,000.00 12 hours ago San Francisco, CA $230,000.00-$245,000.00 5 days ago Associate Director of Regulatory AffairsExec Director, Regulatory Affairs-Combination Products & Devices San Francisco, CA $165,000.00-$200,000.00 1 day ago San Mateo, CA $265,000.00-$295,000.00 2 weeks ago Fremont, CA $179,000.00-$377,000.00 1 week ago Associate Director Regulatory Affairs – APAC - Diabetes Care Alameda, CA $146,700.00-$293,300.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Check out the role overview below If you are confident you have got the right skills and experience, apply today. This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $190,000.00/yr - $240,000.00/yr Additional compensation types Annual Bonus and Stock options Direct message the job poster from Meet Life Sciences Associate Director / Director, Regulatory Affairs – CMC Bay Area, CA | Hybrid (3 days onsite per week) We are partnering with a rapidly growing, pre-IPO biotechnology company advancing first-in-class therapies in oncology and autoimmune diseases. The team is looking for an experienced
Associate Director / Director of Regulatory Affairs – CMC
to play a critical role in shaping and executing regulatory strategies across early-stage programs. This is an opportunity to join a collaborative biotech environment where you’ll work closely with senior leadership, contribute to the development of regulatory plans, and drive cross-functional alignment on CMC and broader regulatory strategies. Key Responsibilities Provide strategic and operational regulatory input, partnering closely with cross-functional teams to ensure alignment on CMC and overall development plans. Contribute to global regulatory strategies, including pre-IND/IND/CTA submissions, risk assessments, and mitigation planning. Lead early-stage regulatory activities with a strong focus on CMC-related aspects while also acting as a regulatory generalist across nonclinical and clinical. Serve as the regulatory representative on project teams, offering guidance, solutions, and support to enable timely development milestones. Draft, review, and finalize regulatory submissions (IND/CTA, NDA/BLA/MAA), ensuring compliance with global health authority requirements. Oversee regulatory input on manufacturing process changes, change control, and global filings. Lead the preparation of responses to regulatory authority queries and participate in meetings with FDA and other global agencies. Stay current on evolving regulatory requirements and communicate updates across internal teams. Qualifications Degree in life sciences, chemistry, chemical engineering, or a related discipline (advanced degree preferred). 8-10+ years of regulatory affairs experience in the biotech/pharma industry, ideally within a dynamic, fast-paced company
(preferably biologics, open to small molecule) Strong track record of successful regulatory submissions and product approvals, with expertise in FDA, ICH, and EMA requirements (UK/EU experience a plus). Exceptional communication, leadership, and interpersonal skills with the ability to engage across all levels of the organization. Apply for full company information and job description! Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionResearch, Science, and Management IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Meet Life Sciences by 2x Get notified about new Director of Regulatory Affairs jobs in
San Francisco Bay Area . Director/Senior Director, Regulatory Affairs StrategyDirector, Regulatory Affairs - Job ID: 1702Executive Director, Regulatory Affairs CMCVice President / Head of Regulatory Affairs San Francisco County, CA $250,000.00-$275,000.00 3 weeks ago Senior Director, Regulatory Affairs - Job ID: 1668 San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702Senior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 5 days ago Transparency and Regulatory Affairs Director Cotati, CA $153,094.00-$169,209.00 1 week ago Foster City, CA $210,000.00-$225,000.00 6 days ago San Francisco Bay Area $180,000.00-$225,000.00 2 weeks ago South San Francisco, CA $196,000.00-$240,000.00 6 days ago Associate Director Regulatory Affairs - Global Regulatory ServicesAssociate Director/Director Regulatory Affairs San Francisco Bay Area $190,000.00-$250,000.00 15 hours ago San Carlos, CA $170,000.00-$220,000.00 12 hours ago San Francisco, CA $230,000.00-$245,000.00 5 days ago Associate Director of Regulatory AffairsExec Director, Regulatory Affairs-Combination Products & Devices San Francisco, CA $165,000.00-$200,000.00 1 day ago San Mateo, CA $265,000.00-$295,000.00 2 weeks ago Fremont, CA $179,000.00-$377,000.00 1 week ago Associate Director Regulatory Affairs – APAC - Diabetes Care Alameda, CA $146,700.00-$293,300.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr