Regulatory CMC Associate Director

Job Summary

Providing strategic and operational support, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-product global regulatory CMC strategies for investigational products, lead regulatory submissions, and manage interactions with Health Authorities, all while working remotely.

Key responsibilities:

• Leads the preparation and review of CMC sections of global regulatory submissions and manages interactions with regulatory agencies
• Provides CMC regulatory guidance to cross-functional teams and key stakeholders, ensuring compliance with EMA/FDA/ICH regulations
• Stays current on evolving regulatory CMC requirements and shares knowledge with team members to support product development

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 education and experience
• Prior experience preparing/authoring CMC sections for BLA, INDs, or post-approval supplements highly preferred
• Experience with regulatory guidelines (FDA, EMA, Health Canada, ICH)
• Strong strategic thinking and problem-solving skills