Sr. Manager, Regulatory Affairs

Role: Regulatory CMC Lead responsible for developing and executing global regulatory strategies for vaccine candidates, focusing on chemistry, manufacturing, and controls (CMC) aspects. Core responsibilities include managing preparation and submission of regulatory CMC documents, coordinating responses to health authority inquiries, ensuring compliance with global regulatory requirements, and providing guidance to cross-functional teams on CMC-related matters. The role involves direct interaction with health authorities and oversight of documentation for filings such as BLA, IND, and IMPD, with specific expertise in module 3.2S and 3.2P. Requirements: Bachelor’s degree in a scientific discipline; 9+ years of experience in biotech or vaccine industry, with prior experience in CMC sections of regulatory filings; proficiency in relevant software tools (e.g., Veeva, SAP, TrackWise); ability to manage multiple projects with high accuracy. Preferred qualifications include prior development or manufacturing experience, and familiarity with vaccine development stages and global regulatory processes. High-Value: Vaccine development, CMC regulatory submissions, biologics, IND/BLA filings, cross-functional collaboration, remote work setup.