Regulatory Project Manager, Cmc Regulatory Affairs

GlaxoSmithKline

Massachusetts, United States
Base: $113,850 to $189,750 (us); bonus/equity: ann...
Hybrid
Cmc regulatory planning and execution
Develop cmc regulatory strategies
Advise on regulations and guidance
You will lead and coordinate Chemistry, Manufacturing and Controls (CMC) regulatory activities across project teams

Job Summary

  • You will lead and coordinate Chemistry, Manufacturing and Controls (CMC) regulatory activities across project teams.
  • This role offers growth, visible impact on product development, and alignment with GSK’s mission to unite science, technology and talent to get ahead of disease together.
  • GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

Matching Summary

You will lead and coordinate Chemistry, Manufacturing and Controls (CMC) regulatory activities across project teams.

Salary

Base: $113,850 to $189,750 (US); Bonus/Equity: Annual bonus and long-term incentive program; Benefits: Health care, insurance, retirement, paid time off

Skills & Requirements

Must-have

  • CMC regulatory planning and execution
  • Develop CMC regulatory strategies
  • Advise on regulations and guidance
  • Coordinate global dossier assembly
  • Support supply continuity
  • Manage timelines and deliverables

Nice-to-have

  • Curious, collaborative, and focused
  • Process improvement and driving efficiencies
  • Practical knowledge of CMC requirements
  • Work independently and collaboratively

Key Requirements

  • Bachelor’s degree or equivalent experience
  • 2+ years' experience in CMC regulatory affairs
  • Experience in pharmaceutical/biopharmaceutical development
  • Direct involvement in regulatory submission preparation

Work Rights

Not specified

Tailored Resume

Cover Letter