Overview:
Celldex is seeking an experienced regulatory leader to drive global regulatory strategies from early development (pre-IND) through registration (BLA) and post-marketing phases. The role requires strategic oversight, cross-functional leadership, and direct engagement with global health authorities.
Key Responsibilities:
- Develop and execute global regulatory strategies across programs
- Serve as primary regulatory contact with health authorities (FDA, EMA, etc.)
- Lead preparation and submission of regulatory documents (INDs, CTAs, BLAs)
- Represent Regulatory Affairs on cross-functional teams
- Monitor global regulatory changes and assess their impact
- Support process improvements and mentor junior staff
Qualifications:
- Bachelor’s in Life Sciences (advanced degree preferred)
- 6–8+ years in Regulatory Affairs within biotech/pharma
- Strong knowledge of FDA, EMA, ICH regulations
- Proven success in global submissions and regulatory interactions
- Excellent leadership, communication, and project management skills
Job sourced from Celldex.