Job Description

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

• 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

• 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

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