Principal Scientist, CMC Regulatory Affairs - Combination Products

• Switzerland
  - Requisition Number: R-094883

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Discovery & Pre-Clinical/Clinical Development

Regulatory Science

Scientific/Technology

• Horsham, Pennsylvania, United States of America
• Raritan, New Jersey, United States of America
• Spring House, Pennsylvania, United States of America
• Titusville, New Jersey, United States of America

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• United States
  - Requisition Number: R-093413
• Belgium, Poland
  - Requisition Number: R-094873
• Switzerland
  - Requisition Number: R-094883

Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, CMC Regulatory Affairs
- Combination Products. This position is a hybrid role and can be located in Raritan, NJ;
Titusville, NJ;
Spring House, PA; or Horsham, PA.

The Principal Scientist, CMC Regulatory Affairs
- Combination Products role will provide CMC (Chemistry, Manufacturing, and Controls) regulatory subject matter expertise for drug-device combination products and related device constituent parts involved in the preparation or administration of drugs. This role may support pre-approval and post-approval programs, synthetic or biologic products, and products in any therapeutic area.

The Principal Scientist will develop and execute regulatory strategies for assigned combination product programs, submissions, Health Authority interactions, and lifecycle management activities. This individual may serve as a core member of the combination product development team and may serve as an ad hoc member of the CMC team (or Value Chain team for post-approval programs), and Global Regulatory Team. This role will also support successful development, registration, and lifecycle management of combination products globally.

This individual will provide subject matter expertise regarding global combination product and global medical device regulatory requirements and is expected to consult with other medical device regulatory experts within Johnson & Johnson Innovative Medicine or Johnson & Johnson Med Tech, as needed. The role will apply in-depth regulatory and scientific knowledge to address complex issues involving one or more related disciplines, establish operational plans for assigned responsibilities, provide guidance to technical and cross-functional colleagues, and contribute to business results through effective regulatory execution.

• Provide regulatory expertise and interpretation of global combination product and global medical device regulatory requirements, including evolving global Health Authority CMC expectations for drug-device combination products, their user interface, and devices, integral or separate, involved in the preparation or administration of drugs.
• Develop and execute regulatory strategies for clinical, marketing, and lifecycle management submissions involving combination products, including regulatory risk assessments and mitigation plans.
• Review device and combination product-specific submission content for clinical trial applications, marketing applications, Notified Body technical dossiers, and development and review of applicable design control deliverables.
• Provide regulatory assessments for manufacturing, device, and product changes and determine regulatory impact globally.
• Develop regulatory strategies for Health Authority interactions, briefing books, and responses related to combination product regulatory questions.
• Participate in cross-functional initiatives related to regulatory process improvements, guidance implementation, and capability development.
• Monitor emerging global device and combination product regulations and communicate regulatory impacts to project teams and management.
• Perform other duties in support of Global Regulatory…