Senior Director Regulatory Affairs
Position Summary
The Senior Director will lead global regulatory strategy and operations across development pipeline. This includes:
- Developing and executing regulatory strategies
- Overseeing submissions: INDs, CTAs, NDAs, BLAs, MAAs
- Partnering with internal teams and external agencies
- Leading regulatory interactions with FDA and ex-US authorities
Key Responsibilities
- Serve as regulatory lead on cross-functional teams
- Prepare and manage regulatory documents and submissions
- Evaluate regulatory risks and develop mitigation strategies
- Maintain regulatory systems, SOPs, and documentation
- Monitor global regulatory changes and provide strategic insights
- Conduct due diligence for business development
- Mentor junior team members
Qualifications
- Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline
- 10+ years in regulatory affairs, 5+ years at Director level or above
- Strong knowledge of FDA and international regulatory bodies (EMA, MHRA, Health Canada)
- Experience with accelerated pathways, eCTD, and RIMS tools
- Background in immunology, dermatology, or rare diseases is a plus
Compensation & Benefits
- Salary: $250,000 - $275,000/year
- Equity: Eligible
- Benefits: Health, dental, vision, pet insurance, 401(k), paid parental leave, life & disability insurance, referral bonuses
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