EPM Scientific
Senior Director Regulatory Affairs
EPM Scientific, San Francisco, California, United States, 94199
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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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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