Regulatory Project Manager

GSK

Poland
Base: pln 183,750 to pln 306,250 gross; bonus/equi...
Cmc regulatory submissions management
Health authority consultation and response
Cross-functional team collaboration
This role plays a critical role in supporting registered vaccines products by managing complex CMC submissions

Job Summary

  • This role plays a critical role in supporting registered vaccines products by managing complex CMC submissions.
  • You will collaborate cross-functionally with diverse teams within the Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations.
  • GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

Matching Summary

This role plays a critical role in supporting registered vaccines products by managing complex CMC submissions.

Salary

Base: PLN 183,750 to PLN 306,250 gross; Bonus/Equity: Eligible for bonus and/or awards for exceptional performance; Benefits: Statutory benefits, private healthcare, additional paid days off, life insurance, private pension plan, fully paid parental leave & care of family member leave

Skills & Requirements

Must-have

  • CMC regulatory submissions management
  • Health Authority consultation and response
  • Cross-functional team collaboration
  • Regulatory strategy planning
  • Dossier preparation (CTD Module 3)

Nice-to-have

  • Mentoring and guiding team members
  • Driving efficiency and innovation
  • Growth mindset and flexibility
  • Strong attention to detail

Key Requirements

  • Advanced degree (Master's or above)
  • Strong experience in CMC Regulatory Affairs
  • Extensive expertise in regulatory strategy planning
  • Sound understanding of pharmaceutical industry and ICH guidelines
  • English writing skills

Work Rights

Not specified

Tailored Resume

Cover Letter