Director, Regulatory Affairs
Core
Formulate and implement regulatory strategies for biopharmaceutical clients in North America, ensuring compliance with government regulations and industry guidelines.
Role type
Director, Regulatory Affairs (Strategic Leadership & Client SME)
Builds
Regulatory submissions (INDs, CTAs, BLAs, MAAs, NDAs) and global regulatory strategies for biopharma clients
Domain
Pharmaceuticals & Biotechnology
Deliverable
client delivery
Required skills
Strategic regulatory planning, FDA and global health authority interaction, biopharmaceutical product lifecycle knowledge (Development, CMC, Labeling, Promotion, Commercialization, Operations), regulatory document preparation, team mentorship, digital process solution development
Preferred skills
Advanced degree (PharmD, PhD, MS), experience with Phase 1-III products, CBER and global biologics expertise, digital technology solution initiation
Technologies
Digital technology solutions for regulatory processes
Responsibilities
Lead client interactions as Subject Matter Expert, oversee regulatory document submissions, monitor regulatory landscape for business opportunities, hire and develop regulatory personnel, collaborate globally on regulatory strategy
Seniority
Director, strategic leadership & mentorship