Project Manager, Cmc Regulatory Affairs

gssi.world

Base: $113,850 to $189,750 (us); pln 236,250 to pl...
Hybrid
Cmc regulatory submission preparation
Drug development and manufacturing
Global cmc regulatory requirements
Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities

Job Summary

  • Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
  • Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit) Hybrid working model (where GSK site are in Poland) Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office , health & well-being activities)

Matching Summary

Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.

Salary

Base: $113,850 to $189,750 (US); PLN 236,250 to PLN 393,750 gross (Poland); Bonus/Equity: Annual bonus and eligibility for share-based long-term incentive program; Benefits: Health care, insurance, retirement, paid holidays, vacation, parental leave, private medical, sports cards, life insurance, pension plan

Skills & Requirements

Must-have

  • CMC regulatory submission preparation
  • drug development and manufacturing
  • global CMC regulatory requirements
  • cross-functional matrix project teams
  • regulatory compliance and continuous improvement

Nice-to-have

  • ambitious for patients
  • accountable for impact
  • committed to doing the right thing
  • innovative approach to regulatory environment

Key Requirements

  • Chemistry, Manufacturing and Controls (CMC) regulatory affairs experience
  • Degree in life sciences or related scientific discipline
  • Knowledge of worldwide CMC regulatory requirements
  • Project management skills

Work Rights

Not specified

Tailored Resume

Cover Letter