Principal Scientist, CMC Regulatory — Combo Products

Johnson & Johnson Innovative Medicine; Allschwil; Hybrid; CHF 170.000 - 230.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine in Allschwil, Switzerland, seeks a Principal Scientist, CMC Regulatory Affairs - Combination Products to provide regulatory subject matter expertise for drug-device combination products. You will develop global regulatory strategies, support submissions, and lifecycle activities across programs.

This hybrid role requires strong cross-functional collaboration, deep regulatory knowledge, and the ability to interact with Health Authorities worldwide, including

Qualifikationen

• Minimum 8 years in Regulatory Affairs, Quality or Product Development.
• Experience in pharma/biotech/medical device or regulated environments.
• Knowledge of regulatory principles and product development.
• Ability to develop and execute regulatory strategies for programs.
• Strong cross-functional collaboration and communication skills.
• Willingness to travel up to 10%.

Aufgaben

• Provide regulatory expertise on global regulatory requirements for drug-device combos.
• Develop and execute regulatory strategies for submissions and lifecycle management.
• Review device and combo-product submissions and design control deliverables.
• Offer regulatory assessments for manufacturing, device changes and global impact.
• Lead health authority interactions and briefing book preparation.
• Participate in cross-functional initiatives to improve regulatory processes.
• Monitor global device and combo-product regulations and communicate impacts.

Kenntnisse

Regulatory Affairs

Regulatory Strategy

Cross-functional Collaboration

CMC Knowledge

Drug-Device Regulation

Regulatory Submissions

Regulatory Writing

Ausbildung

Bachelor’s degree or equivalent

Advanced degree preferred

Jobbeschreibung

Johnson & Johnson Innovative Medicine in Allschwil, Switzerland, seeks a Principal Scientist, CMC Regulatory Affairs - Combination Products to provide regulatory subject matter expertise for drug-device combination products. You will develop global regulatory strategies, support submissions, and lifecycle activities across programs.

This hybrid role requires strong cross-functional collaboration, deep regulatory knowledge, and the ability to interact with Health Authorities worldwide, including