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Senior Director, Regulatory Affairs

Posted about 1 month agoViewed

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💎 Seniority level: Director, 17+ years (14+ with MS, or 10+ with PhD)

💸 Salary: 204300.0 - 306500.0 USD per year

🔍 Industry: Diagnostics, medical device or life sciences technology

🏢 Company: Adaptive Biotechnologies👥 501-1000💰 $125,000,000 Post-IPO Debt over 2 years ago🫂 Last layoff almost 3 years agoBiotechnologyTherapeuticsHealth Care

⏳ Experience: 17+ years (14+ with MS, or 10+ with PhD)

Requirements:
  • BA/BS undergraduate degree in life sciences; MS, PhD or relevant advanced degree preferred.
  • 17+ years of progressive management experience in global regulatory affairs in a diagnostic, medical device or life sciences company.
  • In vitro diagnostics (IVD) experience required.
  • Experience with regulatory submissions in hematology, oncology, immunology or similar fields.
  • Extensive knowledge of compliance requirements and product development lifecycle.
Responsibilities:
  • Provide management and leadership to the Regulatory Affairs team in developing regulatory strategies.
  • Lead planning for regulatory agency meetings and represent Adaptive during negotiations.
  • Monitor and communicate emerging regulations and assess their impact on products.
  • Prepare and oversee regulatory submissions to the FDA and international agencies.
  • Identify regulatory risks related to clinical development and develop mitigation strategies.
  • Collaborate cross-functionally to ensure product compliance and market access.
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