Senior Manager, Regulatory Affairs

Job Summary

Managing registration and CMC regulatory support for commercial and development projects worldwide, the full-time Senior Manager, Regulatory Affairs will prepare and review regulatory submissions for biological products while collaborating with multi-disciplinary teams in a remote environment.

Key responsibilities

• Manage the preparation and review of Module 2 and 3 CTD sections of regulatory submissions for biological products
• Establish Regulatory CMC strategies for commercial products and development programs in collaboration with GRA-CMC leadership
• Coordinate timely submissions and responses to regulatory agencies, ensuring compliance and adherence to timelines

Required qualifications

• BSc/BA with regulatory CMC or related experience
• Demonstrated understanding of FDA, EMA, and ICH guidelines
• Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, INDs, etc.)
• Solid working knowledge of CMC regulatory processes
• Strong interpersonal skills for collaboration with teams and external partners