Senior Director Regulatory Affairs
EPM ScientificSan Francisco County, CA, United States3 days ago
Job type
- Full-time
Job descriptionServe 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 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 Salary : $250,000 - $275,000 / year Equity : Eligible Benefits : Health, dental, vision, pet insurance, 401(k), paid parental leave, life & disability insurance, referral bonuses
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
Qualifications
Compensation & Benefits
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Director Regulatory • San Francisco County, CA, United States