12h ago
Associate Director, Regulatory Affairs
New York, New York
$176.4k-$207.5k / year
full-timelead Remotebiotech
💼 About This Role
You'll lead global regulatory strategies for drug development programs at Recursion, a company reimagining drug discovery through technology. Your core impact is ensuring successful registration and lifecycle management of unique products across multiple jurisdictions. You'll collaborate with cross-functional teams and health authorities to bring high-potential drug candidates to patients faster.
🎯 What You'll Do
- Build relationships and collaborate on global regulatory strategy across jurisdictions
- Provide regulatory guidance and manage day-to-day activities on product teams
- Create and follow procedures for regulatory execution and implementation
- Serve as point of contact with health authorities and lead interactions
📋 Requirements
- 10+ years in pharmaceutical industry with 8+ years in Global Regulatory Affairs
- Experience with major health authorities (US FDA, Health Canada, UK MHRA, EMA)
- 8+ years regulatory submissions (INDs, NDAs, MAAs, PIPs, ODDs, etc.)
- Strong understanding of regulatory strategy and operational implementation
✨ Nice to Have
- Oncology, rare disease, or II experience
- Experience with Breakthrough Designation, EU PRIME activities
🎁 Benefits & Perks
- 🏖️ Remote-friendly work environment
- 💰 Annual bonus and equity compensation
- 🏥 Comprehensive benefits package
- 📈 Estimated $176,400-$207,500 base salary
📨 Hiring Process
Estimated timeline: 2-4 weeks · AI estimate
- 1Recruiter Call· 30 min
- 2Hiring Manager Interview· 45 min
- 3Panel Interview· 60 min
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