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Senior Director Regulatory Affairs

Senior Director Regulatory Affairs

EPM ScientificSan Francisco County, CA, US
1 day ago
Job type
  • Part-time
Job description

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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    Director Regulatory • San Francisco County, CA, US

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