Director, North America Regulatory Affairs Leader

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
• Serve as primary point of contact for US FDA
• Lead the regulatory response team for FDA and Health Canada questions.
• Ensure US Business Partners are consulted and provided input into US regulatory strategies, PMR fulfillments, and other US-related issues.
• 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.
• Directs Managers and/or senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback.
• Establishes major aspects of functional Regulatory Affairs initiatives by taking into account corporate strategies and compliance regulations to drive innovation and ensure timely commercialization of new and modified products into key markets.
• Controls regulatory compliant plans by collaborating with internal stakeholders including Research & Development (R&D), Marketing, and other leaders to create cross-functional policies for driving the optimum portfolio of innovative products.
• Recommends solutions for product development strategies based on anticipated regulatory changes and emerging issues to prevent potential regulatory challenges
• Partners with internal stakeholders to influence regulatory policies and positions to drive convergence between future regulatory policy and functional plans.
• Communicates existing policies and changes in the regulatory environment to management and assists in developing solutions for known issues to implement improvements within the organization.
• Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

We are searching for the best talent for a Director, North America Regulatory Affairs Leader based in Raritan, NJ, Titusville, NJ, or Spring House, PA.

Purpose:
The Director, North America Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies. This role develops and executes robust global and North American regulatory strategies, leads the NA Regulatory Team, and provides strategic direction across cross-functional development teams. The leader ensures NA alignment across portfolio priorities; oversees and critically reviews key regulatory submissions; and leads and supports interactions with FDA. The role also ensures regulatory compliance, supports due diligence, and advances drug development strategies that address global and regional market needs.