Job Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson\'s Family of Companies, is recruiting for a Director, North American/ Global Regulatory Leader (US Regulations Focused). The position can primarily be located in Spring House, PA; Raritan, NJ, Chesterbrook/Malvern PA. Remote work options may be considered on a case-by-case basis and if approved by the Company (in the US or EU).

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Director, North American/ Global Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies. The Director is also responsible for global regulatory strategies for select projects spanning the same target disease areas.

ESSENTIAL FUNCTIONS:

• Responsible for the development, implementation and maintenance of robust North American regulatory strategies.
• Be a key contributor/leader on the Global Regulatory Team and on multiple cross-functional teams.
• Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
• Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
• In interacting with the Health Authorities, the NA/GRL will lead and/or participate in meetings with FDA, Health Canada, and other Health Authorities (HAs) as appropriate.
• Develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.
• Ensure business compliance, and implementation of and adherence to regulatory standards.

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
• Lead the regulatory response team for FDA and Health Canada questions.
• Manage routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities
• Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.

Johnson & Johnson