Inspira Talent
3 days ago Be among the first 25 applicants
Do you have the skills to fill this role Read the complete details below, and make your application today. Inspira Talent is currently partnered with a nimble biotech in SF Bay developing novel biologics for autoimmune disease. They recently raised Series B from leading VC firms to drive their lead program into the clinic. External Description The Head of Regulatory Affairs leads regulatory strategy and operations across this biotech's development programs. This leadership role ensures compliance with FDA, EMA, and global regulatory standards and provides strategic guidance on non-clinical and clinical development. The position partners cross-functionally with clinical, CMC, nonclinical, and executive teams to drive regulatory submissions and agency interactions. Key Responsibilities Regulatory Strategy:
Lead development and execution of global regulatory strategies, particularly for non-clinical and clinical programs. Submissions:
Oversee preparation and submission of INDs, NDAs, BLAs, and MAAs, ensuring accuracy and compliance. Compliance & Intelligence:
Monitor evolving regulatory requirements and guide internal teams accordingly. Agency Interactions:
Act as primary liaison with regulatory bodies, leading meetings and responses. Risk Management:
Identify regulatory risks and advise on mitigation strategies. Qualifications BSc, M.S., Ph.D in a scientific field. 10+ years in pharma/biotech, with 3+ years immunology/autoimmune experience Deep understanding of preclinical, clinical, and regulatory processes. Strong leadership, communication, and cross-functional collaboration skills. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionAdministrative, Research, and General Business IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Inspira Talent by 2x Get notified about new Head of Regulatory Affairs jobs in
San Francisco Bay Area . Director/Senior Director, Regulatory Affairs StrategyVice President / Head of Regulatory AffairsDirector, Regulatory Affairs - Job ID: 1702 San Francisco County, CA $250,000.00-$275,000.00 2 weeks ago Transparency and Regulatory Affairs Director Cotati, CA $153,094.00-$169,209.00 3 days ago Executive Director, Regulatory Affairs CMCSenior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Senior Director, Regulatory Affairs - Job ID: 1668Director, Regulatory Affairs Global Labeling San Francisco Bay Area $295,000.00-$326,000.00 2 weeks ago Director, Global Regulatory Affairs - Neurosciences Palo Alto, CA $188,800.00-$283,200.00 2 weeks ago San Francisco, CA $230,000.00-$245,000.00 2 weeks ago Exec Director, Regulatory Affairs-Combination Products & DevicesDirector, Quality Assurance and Regulatory Affairs San Jose, CA $201,000.00-$251,000.00 2 weeks ago Regulatory Affairs Director - Oncology Cell & Gene Therapy South San Francisco, CA $168,664.00-$252,997.00 6 days ago Associate Vice President of Diagnostics Regulatory AffairsCommercial Regulatory Affairs Director (Advertising and Promotion) Alameda, CA $167,500.00-$237,500.00 2 weeks ago Head of Quality & Compliance, Monarch Platform Santa Clara, CA $200,000.00-$343,850.00 3 days ago Director Life Sciences Regulatory Affairs and Labeling South San Francisco, CA $286,500.00-$374,000.00 3 days ago San Francisco, CA $265,000.00-$315,000.00 2 months ago Head of Compliance and Enterprise Risk ManagementTA HEAD, GLOBAL HEOR | multiple clinical assets - build team | seeking SD / ED / VP | Renowned Boston Pharma San Francisco, CA $115,000.00-$130,000.00 5 days ago San Francisco, CA $115,000.00-$130,000.00 2 months 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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Do you have the skills to fill this role Read the complete details below, and make your application today. Inspira Talent is currently partnered with a nimble biotech in SF Bay developing novel biologics for autoimmune disease. They recently raised Series B from leading VC firms to drive their lead program into the clinic. External Description The Head of Regulatory Affairs leads regulatory strategy and operations across this biotech's development programs. This leadership role ensures compliance with FDA, EMA, and global regulatory standards and provides strategic guidance on non-clinical and clinical development. The position partners cross-functionally with clinical, CMC, nonclinical, and executive teams to drive regulatory submissions and agency interactions. Key Responsibilities Regulatory Strategy:
Lead development and execution of global regulatory strategies, particularly for non-clinical and clinical programs. Submissions:
Oversee preparation and submission of INDs, NDAs, BLAs, and MAAs, ensuring accuracy and compliance. Compliance & Intelligence:
Monitor evolving regulatory requirements and guide internal teams accordingly. Agency Interactions:
Act as primary liaison with regulatory bodies, leading meetings and responses. Risk Management:
Identify regulatory risks and advise on mitigation strategies. Qualifications BSc, M.S., Ph.D in a scientific field. 10+ years in pharma/biotech, with 3+ years immunology/autoimmune experience Deep understanding of preclinical, clinical, and regulatory processes. Strong leadership, communication, and cross-functional collaboration skills. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionAdministrative, Research, and General Business IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Inspira Talent by 2x Get notified about new Head of Regulatory Affairs jobs in
San Francisco Bay Area . Director/Senior Director, Regulatory Affairs StrategyVice President / Head of Regulatory AffairsDirector, Regulatory Affairs - Job ID: 1702 San Francisco County, CA $250,000.00-$275,000.00 2 weeks ago Transparency and Regulatory Affairs Director Cotati, CA $153,094.00-$169,209.00 3 days ago Executive Director, Regulatory Affairs CMCSenior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Senior Director, Regulatory Affairs - Job ID: 1668Director, Regulatory Affairs Global Labeling San Francisco Bay Area $295,000.00-$326,000.00 2 weeks ago Director, Global Regulatory Affairs - Neurosciences Palo Alto, CA $188,800.00-$283,200.00 2 weeks ago San Francisco, CA $230,000.00-$245,000.00 2 weeks ago Exec Director, Regulatory Affairs-Combination Products & DevicesDirector, Quality Assurance and Regulatory Affairs San Jose, CA $201,000.00-$251,000.00 2 weeks ago Regulatory Affairs Director - Oncology Cell & Gene Therapy South San Francisco, CA $168,664.00-$252,997.00 6 days ago Associate Vice President of Diagnostics Regulatory AffairsCommercial Regulatory Affairs Director (Advertising and Promotion) Alameda, CA $167,500.00-$237,500.00 2 weeks ago Head of Quality & Compliance, Monarch Platform Santa Clara, CA $200,000.00-$343,850.00 3 days ago Director Life Sciences Regulatory Affairs and Labeling South San Francisco, CA $286,500.00-$374,000.00 3 days ago San Francisco, CA $265,000.00-$315,000.00 2 months ago Head of Compliance and Enterprise Risk ManagementTA HEAD, GLOBAL HEOR | multiple clinical assets - build team | seeking SD / ED / VP | Renowned Boston Pharma San Francisco, CA $115,000.00-$130,000.00 5 days ago San Francisco, CA $115,000.00-$130,000.00 2 months 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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