Senior Regulatory Specialist, Small Molecules Mature Products, Cmc, Global Regulatory Affairs – Delivery Team

GSK

Poland
Base: pln 144,750 to pln 241,250 gross; bonus/equi...
Hybrid
Cmc regulatory activities
Technical documentation preparation
Regulatory agency inquiries
You’ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business

Job Summary

  • You’ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business.
  • This role will provide YOU the opportunity to lead key activities to progress YOUR career.
  • We’re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference.

Matching Summary

You’ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business.

Salary

Base: PLN 144,750 to PLN 241,250 gross; Bonus/Equity: eligible for a bonus (if applicable); Benefits: Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus

Skills & Requirements

Must-have

  • CMC regulatory activities
  • technical documentation preparation
  • regulatory agency inquiries
  • CMC variations expertise
  • CTD Module 3
  • regulatory intelligence monitoring

Nice-to-have

  • ambitious for patients
  • accountable for impact
  • doing the right thing
  • collaborative environment
  • flexible and analytical thinking

Key Requirements

  • Bachelor's or Master's degree
  • Relevant experience in regulatory affairs
  • Familiarity with post-approval CMC regulatory procedures
  • Understanding of change management processes
  • Ability to handle multiple tasks

Work Rights

Not specified

Tailored Resume

Cover Letter