Principal Scientist, CMC Regulatory Affairs
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Role
Principal Scientist, CMC Regulatory Affairs - Combination Products, providing regulatory expertise for drug-device combination products involving both pharmaceutical and medical device components.
Responsibilities
- Developing regulatory strategies for clinical, marketing, and lifecycle activities;
- Preparing submission content;
- Supporting health authority interactions;
- Ensuring compliance with global regulations such as FDA and EU MDR.
Collaboration
The role involves cross-functional collaboration within Johnson & Johnson's Innovative Medicine and MedTech units, contributing to product development, registration, and lifecycle management.
Qualifications
- Minimum of a Bachelor's in a scientific or engineering discipline, with 8+ years of relevant experience in regulatory affairs, quality, or product development within regulated healthcare environments.
- Preferred skills include experience with combination product development, global regulatory submissions, and knowledge of relevant frameworks (FDA, EU MDR).
- The position requires strong scientific, analytical, and communication skills, with ability to influence cross-functional teams.
Travel
Travel is approximately 10%.
High-Value Specifics
Focus on combination products, drug-device regulation, lifecycle management, and global regulatory strategy.
Work Setup
Hybrid roles in New Jersey or Pennsylvania.
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