Senior Director, CMC Regulatory Affairs

Role Overview

• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.
• Play a hands-on role in planning, preparing, and coordinating CMC documents for submission to global health authorities.
• Partner and work very closely with internal and external cross-functional team members to ensure achievement of submission deadlines.
• Lead and support interactions with FDA and other Health Authorities for CMC-related topics.
• Maintain up-to-date knowledge and understanding of global regulatory requirements.

Requirements

• Masters or PhD degree in a relevant scientific discipline, Advanced degree preferred
• 12+ years of biopharmaceutical experience, which includes at least 6 years of direct experience in Regulatory Affairs CMC
• Demonstrated, hands-on experience in biologics drug development, registration, and post-approval life cycle management in a global environment.
• Comprehensive understanding of CMC product development with biologics and drug-device combinations and knowledge of applicable global regulations, guidance, and practices
• Experience in the preparation and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, and agency queries.

Benefits

• Medical, dental, vision insurance
• 401k
• Unlimited paid time off
• Parental leave