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Associate Director, Global Regulatory Policy & Intelligence
Requisition ID: 7975180404
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, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
- The Policy Lead takes a leadership role in Identifying regulatory and legislative issues that have the potential to impact the development and marketing of J&J’s pharmaceutical products
- Providing strategic input and tactical support to global project teams throughout the product lifecycle, with the goal of empowering informed decision-making to bring products to market and maintain their availability for patients
- Partnering with global or regional subject matter experts and groups including Local Operating Companies to engage in direct regulatory advocacy and influencing activities relating to regulatory policies
- Actively engaging in Trade Association initiatives, Health Authority policy-focused meetings, and consultation and contribution to global pharmaceutical commenting efforts;
- Acting in a liaison role with the Janssen US regulatory community, supporting US regional regulatory affairs and compound development teams with focused regulatory strategies for FDA interactions, product development, and submissions to FDA.
- A minimum of a Bachelor’s degree is required, advanced degree preferred.
- A Bachelor’s degree with minimum of 8 years regulatory policy or advocacy experience, or Master’s degree with minimum 6 years regulatory policy or advocacy experience required.
- Five years of internal FDA experience highly preferred.
- Must have expert knowledge about FDA, FDA staff and FDA policies.
- Must also have a broad and thorough understanding of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
- Must have the ability to analyze new regulations or policies and assess the impact on the J&J pharmaceutical business or development programs.
- Excellent oral and written communication skills are essential for the position.
- This position may require up to 10% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)