Senior Principal Scientist, CMC Regulatory Affairs - Combination Products
Johnson & Johnson
Senior Principal Scientist role leading regulatory strategy for combination products at Johnson & Johnson's Innovative Medicine division. The position requires expertise in CMC (Chemistry, Manufacturing, and Controls) regulatory affairs, global medical device requirements, and complex product development across therapeutic areas. Based in Allschwil, Switzerland as a hybrid role.
Responsibilities
- Lead CMC regulatory strategy for complex, novel, or high-risk combination product programs
- Develop global regulatory strategies for clinical, marketing, and lifecycle management submissions
- Provide expert interpretation of evolving combination product and medical device regulatory requirements
- Mentor and coach regulatory and cross-functional colleagues on regulatory matters
- Represent Johnson & Johnson in external regulatory, industry, and scientific forums
Requirements
- Advanced degree in chemistry, pharmaceutical sciences, or related field
- Extensive experience with combination product and medical device regulatory affairs
- Expert knowledge of global regulatory requirements for drug-device combinations
- Demonstrated scientific and technical leadership in complex regulatory programs
- Experience representing organizations in regulatory and industry forums
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