Project Manager, Cmc Regulatory Affairs

GSK

Cambridge, MA, US
Base: $113,850 to $189,750 (us); pln 236,250 to pl...
Hybrid
Cmc regulatory affairs experience
Regulatory submission preparation
Drug development and manufacturing
Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products

Job Summary

  • Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
  • 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.
  • GSK offers a hybrid working model, personalized learning approach, and a supportive community with integration events.

Matching Summary

Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

Salary

Base: $113,850 to $189,750 (US); PLN 236,250 to PLN 393,750 gross (Poland); Bonus/Equity: Annual bonus & share based long term incentive program (US); Awards for outstanding performance (Poland); Benefits: Health care and other insurance benefits, retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave (US); Private medical package, Life insurance, pension plan, Sports cards, fully paid parental leave (Poland)

Skills & Requirements

Must-have

  • CMC regulatory affairs experience
  • Regulatory submission preparation
  • Drug development and manufacturing
  • Worldwide CMC regulatory requirements
  • Cross-functional matrix project teams

Nice-to-have

  • Ambitious for patients
  • Accountable for impact
  • Doing the right thing
  • Continuous improvement
  • Innovative approach

Key Requirements

  • Degree in life sciences or related scientific discipline
  • Experience in CMC regulatory affairs or product development
  • Knowledge of drug development, manufacturing processes and supply chain
  • Good time management skills
  • Demonstrated knowledge of project management components

Work Rights

Not specified

Tailored Resume

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