Regulatory CMC Associate Director

Job Summary

Hands-on and strategic, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-product global regulatory CMC strategies for investigational products, manage regulatory submissions, and provide guidance to cross-functional teams while working remotely.

Key responsibilities:

• Leads the preparation and review of CMC sections of global regulatory submissions and manages interactions with regulatory agencies
• Defines CMC content requirements for regulatory submissions and ensures compliance with established regulations
• Stays updated on evolving regulatory CMC requirements and provides guidance to cross-functional teams on compliance topics

Required qualifications:

• Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Regulatory Affairs)
• Minimum 10 years of experience in the vaccine or biotech industry, or equivalent combination of education and experience
• Prior experience preparing/authoring CMC DS sections, with BLA and IND experience highly preferred
• Advanced knowledge of regulatory guidelines (FDA, EMA, Health Canada, ICH)
• Strong strategic thinking and problem-solving skills