Associate Director, Regulatory Affairs - Raritan New Jersey

Company: Disability Solutions
Location: Raritan, New Jersey
Posted On: 04/21/2024

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. This position can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company. 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 www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development. Principal Responsibilities:

• Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist.
• Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional regulatory strategies.
• Drive the execution of regulatory plan for select projects through close collaboration with multiple functional areas.
• Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensure strategy is in alignment with NA regional teams, Chemistry, Manufacturing, and Controls (CMC), commercial strategies, and the Target Product Profile.
• Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands).
• Own the preparation of regulatory dossiers for submissions to U.S. and Canada.
• Lead the preparation for and participate in meetings with Health Authorities (HAs) in the U.S. and Canada.
• Serve as a member of the Labeling Working Group to create or update the Company Core Data Sheet (CCDS) and contribute to the development of local labels as appropriate.
• Provide regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
• Ensure compliance with internal and external policies and legislation.
• Support or lead Due Diligence activities as appropriate.
• Assume personal ownership and accountability for business results and solutions; identify problems, obstacles or opportunities and act to address current or future problems or opportunities. More...

      

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