Allucent

Associate Director, Regulatory Affairs

Allucent

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

About the role

  • Step into a leadership role guiding clients through the complexities of drug, biologic, and medical device development—leading teams, shaping strategies, and ensuring successful submissions.
  • You’ll be the trusted expert who turns regulations into real-world impact on global healthcare.
  • Lead and mentor regulatory teams; shape strategies; ensure the delivery of high-quality, scientifically sound submissions.
  • Serve as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
  • Review and author regulatory and scientific documents while driving successful outcomes for clients.
  • Act as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans. In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
  • Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
  • Reviews and prepares HA meeting requests and briefing documents.
  • Provide specialized CMC regulatory expertise across both pre-and post marketing strategies.
  • Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
  • Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management.
  • Has advanced knowledge of CTD format and structure for regulatory submissions.

Requirements

  • Requires a B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
  • 6 years’ experience with regulatory requirements of US FDA, Health Canada and / or European authorities
  • Experience with CMC regulatory pre and post marketing
  • Regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and / or Canada