Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Americas Policy Lead, Global Regulatory Policy & Intelligence. The position will be based in Rockville, MD; Spring House, PA; Titusville, NJ; or Raritan, NJ.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Immunology, Metabolic, Mental Health, Oncology, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Director, Americas Policy Lead, Global Regulatory Policy & Intelligence will:
• Identify regulatory and legislative issues, trends, and changes that could impact the development and marketing of pharmaceutical products.
• Provide high quality strategic input and tactical support to global product teams throughout the product lifecycle.
• Partner with global and regional subject matter experts and groups including Government Affairs and Local Operating Companies to engage in direct legislative and regulatory advocacy and influencing activities.
• Actively engage in Trade Association initiatives, Health Authority policy-focused meetings, and global pharmaceutical commenting efforts on legislation, regulations, guidances, and other regulatory policies.
• Liaison with the Janssen US regulatory community, supporting US regional regulatory affairs and compound development with focused regulatory strategy support for FDA interactions, product development, and submissions to FDA, including by interpreting Agency statements and actions and providing advice and guidance on achieving successful FDA outcomes.
• Collaborate with Janssen intelligence and knowledge management staff to ensure effective and timely dissemination of regulatory information and intelligence.
• A minimum of a Bachelor’s degree is required, preferably in a science or health-related discipline.
• An advanced degree in law, pharmacy, medicine, or a life science-related discipline is preferred.
• A minimum of 10 years of relevant experience in a regulated environment is required.
• Pharmaceutical policy and regulatory experience is required.
• A minimum of 5 years internal FDA experience is required.
• Broad and thorough understanding of the Federal Food, Drug, and Cosmetic Act and its implementing regulations is required.
• Ability to analyze new pharmaceutical regulations or policies and assess the impact on business or development programs is required.
• This position will be located in Rockville, MD; Spring House, PA; Titusville, NJ; or Raritan, NJ, and require approximately 10-20% regional travel.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
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