Regulatory Project Manager

gssi.world

Poland
Base: pln 183,750 to pln 306,250 gross; bonus/equi...
Not specified (assumed to be hybrid or onsite based on typical industry practices).
Cmc regulatory submissions
Regulatory strategy planning
Dossier preparation (ctd module 1-3)
GSK is seeking a Regulatory Project Manager to join their CMC Delivery team in Poland, focusing on managing complex regulatory submissions and ensuring compliance for vaccine products. The ideal candidate will have extensive experience in CMC regulatory affairs and strong analytical and interpersonal skills

Job Summary

  • Manage complex CMC submissions for registered vaccines products, addressing regulatory requirements across global markets.
  • Collaborate cross-functionally with diverse teams to build high-quality components for global regulatory dossiers.
  • Identify improvement opportunities for CMC Regulatory processes and develop simplified working practices to enhance efficiency and quality.

Matching Summary

Match Score: 85

GSK is seeking a Regulatory Project Manager to join their CMC Delivery team in Poland, focusing on managing complex regulatory submissions and ensuring compliance for vaccine products. The ideal candidate will have extensive experience in CMC regulatory affairs and strong analytical and interpersonal skills.

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
  • Regulatory strategy planning
  • Dossier preparation (CTD Module 1-3)
  • Cross-functional team collaboration
  • ICH guidelines and requirements

Nice-to-have

  • Growth mindset
  • Interpersonal skills
  • Attention to detail

Key Requirements

  • Master's degree or above in a life science field
  • Strong experience in CMC Regulatory Affairs
  • Sound understanding of pharmaceutical industry and drug development
  • English writing skills
  • Excellent organizational skills

Work Rights

Not specified

Tailored Resume

Cover Letter