Regulatory Project Manager

GSK

Poland
Base: pln 183,750 to pln 306,250 gross; bonus/equi...
Cmc regulatory submissions
Health authority consultations
Ctd module 3 quality section
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)

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 take on a key role in ensuring the timely and efficient delivery of regulatory activities across multiple CMC projects within the Vx business.
  • All statutory benefits will be maintained in accordance with Polish law.

Matching 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).

Salary

Base: PLN 183,750 to PLN 306,250 gross; Bonus/Equity: eligible for a bonus (if applicable); 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
  • Health Authority consultations
  • CTD Module 3 quality section
  • cross-functional team collaboration
  • process improvement identification

Nice-to-have

  • mentoring and guiding team members
  • growth mindset
  • interpersonal skills

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
  • English writing skills

Work Rights

Not specified

Tailored Resume

Cover Letter