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