Allucent

VP, Chemistry, Manufacturing and Controls – CMC

Allucent

contract

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

About the role

  • Lead Regulatory Writing & Strategy: Write, review, and guide CMC documents and submissions with accuracy and insight.
  • Shape Product Development: Influence strategies and plans from early development through post-approval.
  • Engage with Health Authorities: Lead meetings, prepare briefing packages, and serve as the expert voice in regulatory interactions.
  • Provide Scientific Leadership: Share expertise in CMC, compliance, and audits while mentoring teams and supporting client success.
  • Drive Collaboration & Solutions: Partner with clients and cross-functional teams to solve challenges and deliver innovative outcomes.

Requirements

  • Advanced scientific and regulatory knowledge of drug, biologic, or device development
  • Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
  • Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
  • 15 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable