Regulatory Affairs Manager

Executing regulatory strategies for therapeutic programs, the full-time Manager, Regulatory Affairs will manage high-quality regulatory submissions and provide guidance to cross-functional teams, with the flexibility to work either onsite in New York City or remotely. Key responsibilities Participate in the development and implementation of regulatory strategies from candidate selection through post-marketing support Coordinate the authoring, editing, and submission of regulatory documents, ensuring compliance with all relevant requirements Monitor the evolving regulatory landscape for cell and gene therapy and communicate recommendations to management and project teams Required qualifications BS, MS, or PhD degree in a scientific discipline 5-7 years of experience in biotechnology with at least 3 years in Regulatory Affairs, or equivalent experience with advanced degrees Experience with biologic and/or gene therapy products preferred Knowledge of GCP, GLP, GMP, and FDA and ICH guidelines RAPS certification preferred but not required