Inspira Talent
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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 level Director Employment type
Employment type Full-time Job function
Job function Administrative, Research, and General Business Industries Biotechnology 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
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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 level Director Employment type
Employment type Full-time Job function
Job function Administrative, Research, and General Business Industries Biotechnology 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 Strategy
Vice President / Head of Regulatory Affairs
Director, 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 CMC
Senior 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: 1668
Director, 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 & Devices
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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.
#J-18808-Ljbffr