Senior Principal Scientist, CMC Regulatory Affairs - Combination Products
$137k - $235.75kJohnson & Johnson
Senior Principal Scientist role leading regulatory strategy and compliance for combination products at Johnson & Johnson's Innovative Medicine division. Reports to senior management and provides expert guidance on global regulatory requirements, drug-device integration, and lifecycle management across multiple therapeutic areas.
Responsibilities
- Serve as lead regulatory scientist for complex combination product development programs
- Develop global regulatory strategies for clinical, marketing, and lifecycle management submissions
- Provide expert interpretation of evolving health authority expectations and regulatory requirements
- Lead regulatory risk assessments, mitigation planning, and contingency strategies
- Represent organization in external regulatory forums and industry working groups
Requirements
- Extensive experience in combination product regulatory affairs and CMC strategy
- Deep knowledge of global regulatory requirements for drug-device products
- Proven expertise in clinical, marketing, and post-approval regulatory submissions
- Strong scientific and technical foundation in chemistry, manufacturing, and controls
- Track record of leading complex, high-risk regulatory programs
- Demonstrated ability to mentor and provide technical leadership to cross-functional teams
Vacancy posted 4 days ago
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