Regulatory Project Manager, Cmc Regulatory Affairs

GSK

Base: $113,850 to $189,750 (us); base: pln 236,250...
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Cmc regulatory planning and execution
Develop cmc regulatory strategies
Advise cross-functional teams on regulations
** GSK is seeking a Regulatory Project Manager for CMC Regulatory Affairs to lead and coordinate regulatory activities across project teams, focusing on high-quality submissions within the pharmaceutical development sector. The role emphasizes collaboration, practical solutions, and clear communication while contributing to the company's mission of advancing health through innovation. **

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.
  • The annual base salary in Poland for new hires in this position ranges from PLN 236,250 to PLN 393,750 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role.

Matching Summary

Match Score: 75

** GSK is seeking a Regulatory Project Manager for CMC Regulatory Affairs to lead and coordinate regulatory activities across project teams, focusing on high-quality submissions within the pharmaceutical development sector. The role emphasizes collaboration, practical solutions, and clear communication while contributing to the company's mission of advancing health through innovation. **

Salary

Base: $113,850 to $189,750 (US); Base: PLN 236,250 to PLN 393,750 gross (Poland); Bonus/Equity: Annual bonus and eligibility for long-term incentive program (US); Benefits: Health care, retirement, paid time off (US); Statutory benefits, private healthcare, additional paid days off, life insurance, private pension plan, fully paid parental leave (Poland)

Skills & Requirements

Must-have

  • CMC regulatory planning and execution
  • Develop CMC regulatory strategies
  • Advise cross-functional teams on regulations
  • 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
  • Ability to 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