GSK·13 days ago
13 days ago
Regulatory Manager, Strategy - CMC RA Small Molecules Mature Products"
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What you'll do
- Provide CMC support for a portfolio of marketed small molecule products
- Lead regulatory strategy
- Ensure compliance
- Collaborate with cross-functional teams
What they're looking for
- Experience in CMC regulatory affairs
- Background in pharmaceutical sciences
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Take on the role of Regulatory Manager, Strategy to provide CMC support for a portfolio of marketed small molecule products globally. Lead regulatory strategy, ensure compliance, and collaborate with cross-functional teams. Ideal for candidates with experience in CMC regulatory affairs and a background in pharmaceutical sciences.
Skills
- regulatory strategy
- cmc regulatory affairs
- regulatory compliance
- post-approval management
- regulatory dossier preparation
- regulatory risk management
- learning agility
- regulatory strategies
- pharmaceutical regulatory compliance
- problem solving
- communication
- digital fluency
- strategic leadership
- influencing without authority
- cross-functional collaboration
- fda interaction
- good manufacturing practices
- change control
- supply chain continuity
- stakeholder management
- regulatory process improvement
- electronic dossier format
- manufacturing change management
- written communication
- verbal communication
- negotiation
- matrix management
Company
GSK
Durham, United States of America
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