Regulatory Project Manager

gs জৈcare

Base: pln 183,750 to pln 306,250 gross; bonus/equi...
Not specified (assumed as hybrid/onsite based on industry norms)
Cmc regulatory submissions
Health authority consultations
Active pharmaceutical ingredients
GSK is seeking a Regulatory Project Manager to lead complex CMC submissions for vaccines, ensuring compliance with regulatory standards. The ideal candidate will possess advanced qualifications in a relevant scientific field and have substantial experience in CMC Regulatory Affairs within the pharmaceutical industry

Job Summary

  • The CMC Mature Vx Delivery Lead plays a critical role in supporting registered vaccines products by managing complex CMC submissions (such as CMC Post-approval variations, Health Authorities consultations or responses to Health Authorities questions).
  • You will collaborate cross-functionally with diverse teams within the Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations to contribute to the development of high-quality components for global regulatory dossiers.
  • The annual base salary in Poland for new hires in this position ranges from PLN 183,750 to PLN 306,250 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: 85

GSK is seeking a Regulatory Project Manager to lead complex CMC submissions for vaccines, ensuring compliance with regulatory standards. The ideal candidate will possess advanced qualifications in a relevant scientific field and have substantial experience in CMC Regulatory Affairs within the pharmaceutical industry.

Salary

Base: PLN 183,750 to PLN 306,250 gross; Bonus/Equity: potentially eligible for a bonus; Benefits: statutory benefits in accordance with Polish law, 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
  • Health Authority consultations
  • Active Pharmaceutical Ingredients
  • Drug Products
  • global markets
  • dossier preparation

Nice-to-have

  • operational efficiency
  • foster innovation
  • cross-functional collaboration
  • mentoring and guiding team members

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
  • Excellent interpersonal skills
  • Excellent organizational skills

Work Rights

Not specified

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