Project Manager, Cmc Regulatory Affairs

GlaxoSmithKline

Cambridge, MA, USA
Base: $113,850 to $189,750 (us); base: pln 236,250...
Hybrid
Cmc regulatory affairs experience
Regulatory submission preparation
Drug development
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 fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

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

Skills & Requirements

Must-have

  • CMC regulatory affairs experience
  • regulatory submission preparation
  • drug development
  • manufacturing processes
  • supply chain knowledge
  • global CMC regulatory requirements

Nice-to-have

  • ambitious for patients
  • accountable for impact
  • doing the right thing
  • continuous improvement
  • innovative approach

Key Requirements

  • Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience
  • Degree in life sciences or related scientific discipline
  • Sound knowledge of drug development, manufacturing processes and supply chain
  • Knowledge of worldwide CMC regulatory requirements
  • Good time management skills
  • Demonstrated knowledge of project management components

Work Rights

Not specified

Tailored Resume

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