Sr Mgr, Regulatory Affairs
$152k - $209kBaxter Healthcare
Senior Manager of Global Regulatory Affairs leads regulatory strategy development and execution for biologic/combination products across international markets. The role coordinates cross-functional teams on filings, compliance, and product lifecycle management while serving as strategic advisor to leadership on regulatory matters.
Responsibilities
- Serve as global regulatory lead for hemostat and sealant biologic/combination products
- Provide technical and strategic input on regulatory decisions aligned with business strategy
- Monitor regulatory requirements, assess compliance, and implement mitigation plans for identified risks
- Act as primary contact for regulatory authority meetings and manage complex projects
- Mentor junior colleagues on US regulatory requirements and submission strategies
Requirements
- Bachelor's degree in scientific discipline; Master's or PhD preferred
- Minimum 7 years regulatory affairs experience
- Expert regulatory knowledge with scientific training background
- Management and leadership skills with ability to coach others
- Strong oral and written communication and presentation abilities
- Ability to manage multiple projects in matrix environment
- Experience working in multinational and multicultural settings
Compensation: $152,000 - $209,000 base annually
Vacancy posted 29 days ago
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