Sr. Manager, Regulatory Affairs
Core
Develops and executes multi-product global regulatory CMC strategies for investigational vaccines and leads the preparation and filing of regulatory CMC submissions.
Role type
Senior Manager, Regulatory Affairs (CMC)
Builds
Investigational vaccine products for global markets
Domain
Biotechnology / Vaccines / Regulatory Affairs
Required skills
Global regulatory strategy, CMC submission preparation, Health Authority interaction, Change control management, Cross-functional collaboration, Regulatory surveillance
Preferred skills
BLA/IND/IMPD authoring experience, Module 3.2S/3.2P expertise, Manufacturing experience
Technologies
LIMS, SAP, TrackWise, Veeva
Responsibilities
Manage documentation collection and preparation for regulatory CMC submissions; Coordinate responses to queries from regulatory authorities; Review and approve change controls related to product/process changes; Provide regulatory CMC guidance to cross-functional teams; Conduct routine regulatory surveillance and communicate new regulations.
Seniority
Senior, hands-on IC with strategic oversight