Director of Regulatory Affairs

A company is looking for a Director, Regulatory. Key Responsibilities: Develop and execute regulatory strategies for cell therapy products, managing all regulatory aspects through pivotal studies and BLA/MAA approval Prepare and oversee regulatory submissions, ensuring compliance with current regulations and guidelines Represent the company in interactions with regulatory agencies, building and maintaining positive relationships to facilitate approvals Qualifications: Bachelor's degree in life sciences or related field required (advanced degree preferred) Minimum of 8 years of experience in regulatory affairs for biopharmaceuticals or cell therapy Strong understanding of the drug development process from pre-clinical to commercialization, with prior BLA experience required Experience in reviewing and writing regulatory submission documents for global regulatory filings Knowledge of GXPs and key requirements for regulatory submissions in ICH regions

Created: 2026-03-05