Regulatory Project Manager, Cmc Regulatory Affairs

GSK

Cambridge, MA, United States
Base: $113,850 to $189,750 (us); base: pln 236,250...
Hybrid
Bachelor's degree in pharmacy or chemistry
2+ years cmc regulatory affairs experience
Direct involvement in regulatory submission preparation
GSK is seeking a Regulatory Project Manager for CMC Regulatory Affairs to lead and coordinate regulatory activities related to Chemistry, Manufacturing, and Controls. The ideal candidate should have experience in CMC regulatory affairs, preferably within the pharmaceutical or biopharmaceutical sectors, and will work in a hybrid model at various locations in the U.S

Job Summary

  • The role involves leading Chemistry, Manufacturing and Controls (CMC) regulatory planning and execution across project teams to deliver high-quality submissions.
  • GSK aims to positively impact the health of 2.5 billion people by uniting science, technology, and talent to get ahead of disease together.
  • This position offers a hybrid work model with eligibility for an annual bonus and share-based long-term incentive programs.

Matching Summary

Match Score: 85

GSK is seeking a Regulatory Project Manager for CMC Regulatory Affairs to lead and coordinate regulatory activities related to Chemistry, Manufacturing, and Controls. The ideal candidate should have experience in CMC regulatory affairs, preferably within the pharmaceutical or biopharmaceutical sectors, and will work in a hybrid model at various locations in the U.S.

Salary

Base: $113,850 to $189,750 (US); Base: PLN 236,250 to PLN 393,750 (Poland); Bonus/Equity: Annual bonus and share-based long term incentive program eligible; Benefits: Health care, retirement, paid holidays, vacation, parental leave

Skills & Requirements

Must-have

  • Bachelor's degree in pharmacy or chemistry
  • 2+ years CMC regulatory affairs experience
  • Direct involvement in regulatory submission preparation

Nice-to-have

  • Experience with vaccines or biologics
  • Advanced degree in scientific field
  • Familiarity with US and EU regulatory requirements
  • Proven ability to influence stakeholders
  • Comfort with process improvement

Key Requirements

  • Bachelor's degree in pharmacy, chemistry, biotechnology
  • 2+ years experience in CMC regulatory affairs
  • Experience preparing global submissions

Work Rights

Not specified

Tailored Resume

Cover Letter