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 (Master's 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 (Master's 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