Sr. Manager, Regulatory Affairs

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.

Essential Functions:

• Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
• Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
• Manage preparation of responses to queries from regulatory authorities.
• Ensure conformance to commitments made with various regulatory agencies.
• Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks.
• Manage coordination, preparation, and timely submission of regulatory documents and filings.
• Review and approve change controls related to proposed product/process changes and asses their impact against regulatory requirements.
• Cultivate productive working relationships with the Regulatory team and other departments.
• Coordinate responses to CMC-related queries from Health Authorities.

Requirements:

• Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
• 9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
• Prior experience preparing/authoring CMC DS sections:
  • BLA highly preferred.
  • IND highly preferred.
  • IMPD.
• Prior development or manufacturing experience is a plus.
• Experience with module 32S and 32P.
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).