Head of Regulatory Affairs

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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

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