Director, Regulatory Affairs - Pharmaceuticals
Stryker(1 month ago)
About this role
The Director, Regulatory Affairs - Pharmaceuticals leads the regulatory affairs organization supporting a business unit’s drug and combination products. This role provides leadership and people management while partnering with cross-functional leaders to set global regulatory strategy, oversee submissions and approvals, and ensure regulatory and quality compliance. The position represents the company with regulatory agencies and drives regulatory direction for product development and commercialization.
Required Skills
- Regulatory Strategy
- Drug Development
- FDA Interactions
- Submissions
- Quality Assurance
- Team Management
- Crossfunctional Collaboration
- Compliance
- Combination Products
- Product Approval
Qualifications
- BS in Engineering or Science
- RAC
- Masters in Regulatory Affairs (preferred)
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