Manager, Regulatory Affairs

Job description

The Role: We are seeking a proactive and experienced Regulatory Affairs Manager to lead and coordinate global regulatory activities supporting the development of our biologic therapeutics. This role will independently manage key submission components, contribute to regulatory strategy, and help drive compliance with global regulatory standards. You will work cross-functionally to influence planning and execution of development programs, helping ensure alignment with evolving regulatory requirements. The ideal candidate brings hands-on regulatory experience, strong technical and writing skills, and the ability to operate independently in a fast-paced, dynamic environment. Here's how you will contribute: - Independently lead the preparation and coordination of regulatory submissions (e.g., INDs, CTAs, amendments, annual reports), including timeline and content planning. - Act as primary author for select regulatory sections and submission documents. - Coordinate and draft responses to health authority queries in collaboration with cross-functional teams. - Represent Regulatory Affairs at cross-functional meetings and contribute to program development discussions. - Interpret evolving...