Senior Director Regulatory Affairs - San Francisco, CA, United States - Scipro

Description

Senior Director, Regulatory Affairs

San Francisco, CA (Hybrid)

Join this Bioscience company on the forefront of groundbreaking therapeutics I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based therapeutic programs, guiding them from inception to market success.

Key Responsibilities

• Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology
• Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge of US and EU
• Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities
• Serve as a liaison between the company and regulatory agencies

Required Qualifications

• Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry (Masters degree with 8+ years of experience or PhD with 6+ years of experience); Sr. Director: Minimum of 12+ years of experience in the biotechnology and/or biopharmaceutical industry (Masters degree with 10+ years of experience or PhD with 8+ years of experience).
• Experience with US and clinical trial submissions through with CBER/OTAT or ex-US equivalent
• Experience with gene therapy products regulatory requirements
• Bachelors degree in life sciences

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