Base: $173,250 to $288,750 (us); bonus/equity: ann...
Hybrid
Extensive cmc regulatory experience in biopharmaceuticals
Degree in biological sciences or related field
Experience with development and manufacturing requirements
This role offers the opportunity to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products across GSK's R&D and commercial teams
Job Summary
This role offers the opportunity to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products across GSK's R&D and commercial teams.
The position involves advising on regulations, managing submission content, and identifying regulatory risks to expedite approval of global CMC applications.
GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing while uniting science, technology, and talent.
Matching Summary
This role offers the opportunity to lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products across GSK's R&D and commercial teams.
Salary
Base: $173,250 to $288,750 (US); Bonus/Equity: Annual bonus and share-based long term incentive program; Benefits: Health care, retirement, paid holidays, vacation, parental leave
Skills & Requirements
Must-have
Extensive CMC regulatory experience in biopharmaceuticals
Degree in biological sciences or related field
Experience with development and manufacturing requirements
Nice-to-have
Advanced degree (MSc or PhD) in scientific discipline
Experience leading CMC regulatory teams
Experience with cell and gene therapies
Proven track record preparing global CMC submissions
Strong written and verbal communication skills
Key Requirements
Degree in biological sciences, chemistry, pharmacy, engineering
Extensive CMC regulatory experience in biopharmaceuticals