Director, Regulatory Affairs

Allucent

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Role summary

Director of Regulatory Affairs at Allucent will lead regulatory teams guiding clients through drug, biologic, and medical device development. The role involves strategic planning, Health Authority interactions, document preparation, and project oversight to advance innovative therapies.

What they're looking for

B.Sc., M.Sc., Ph.D., or equivalent degree in scientific discipline
8+ years experience with US FDA, Health Canada, and/or European regulatory requirements
Advanced knowledge of drug, biologic, or device development regulations
Expertise in Common Technical Document (CTD) format and structure
Demonstrated ability to lead and mentor regulatory teams

What you'll be doing

Lead and mentor regulatory teams while shaping development strategies
Serve as Subject Matter Expert or Consulting Lead across diverse project teams
Review, prepare, and author regulatory and scientific submissions and HA meeting documents
Oversee and manage regulatory projects of varying complexity levels
Translate regulatory requirements into actionable plans and provide strategic advisory support

Privacy & handoff

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RoleLantern checkedNeeds clarity

Date posted10 days ago

Last source check1 day ago

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