Regulatory Affairs Manager

Job Summary

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