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
This role offers the opportunity to lead CMC regulatory planning and execution while adapting to shifting priorities across project teams

Job Summary

  • This role offers the opportunity to lead CMC regulatory planning and execution while adapting to shifting priorities across project teams.
  • Candidates will work closely with development, manufacturing, and quality teams to align technical and regulatory approaches for timely submissions.
  • The position includes eligibility for an annual bonus, share-based long-term incentives, and comprehensive benefits including health care and paid leave.

Matching Summary

This role offers the opportunity to lead CMC regulatory planning and execution while adapting to shifting priorities across project teams.

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 or regulatory field
  • Proven ability to influence stakeholders
  • Familiarity with US and EU regulatory requirements

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter