ApplySenior Director, Regulatory Affairs
Posted 2 months agoViewed
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💎 Seniority level: Director, 17+ years (14+ with MS, or 10+ with PhD)
📍 Location: United States
💸 Salary: 204300.0 - 306500.0 USD per year
🔍 Industry: Life Sciences
🏢 Company: Adaptive Biotechnologies👥 501-1000💰 $125,000,000 Post-IPO Debt over 2 years ago🫂 Last layoff almost 3 years agoBiotechnologyTherapeuticsHealth Care
🗣️ Languages: English
⏳ Experience: 17+ years (14+ with MS, or 10+ with PhD)
🪄 Skills: LeadershipRisk Management
Requirements:
- BA/BS in life sciences; MS, PhD preferred
- 17+ years in global regulatory affairs
- In vitro diagnostics (IVD) experience
- Experience with diagnostic product regulatory submissions
- Expertise with product development lifecycle
- Hands-on experience in US regulatory filings
Responsibilities:
- Manage and lead the Regulatory Affairs team
- Plan and prepare for regulatory agency meetings
- Monitor global regulatory trends and guidelines
- Oversee preparation of regulatory documents
- Provide regulatory guidance and training
- Serve as primary contact with regulatory agencies
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