Johnson & Johnson Careers
Associate Director, Regulatory Affairs
Requisition ID: 8015180726
Johnson & Johnson Consumer Inc. is currently recruiting for an Associate Director, Regulatory Affairs, to be based in Fort Washington, PA.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees.
Johnson & Johnson Consumer Inc. develops and markets beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business franchises: Baby Care, Oral Care, Compromised Skin Care, Beauty Care, Feminine Care, Eye Care and Over-The-Counter (OTC) products.
This position resides within the R&D organization, Global Regulatory Affairs function, and will report to the Director, Global Regulatory Affairs. The Associate Director, Global Regulatory Affairs (RA), in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, provides support for key brands and a number of innovation projects that may include a range of Regulatory classifications (New Drug Application (NDA) or Marketing Authorization Application (MAA) and Monograph Drugs, Dietary Supplements, Medical Devices, combination products).
- The company operates in a highly regulated business environment. Many of the products in the OTC portfolio are approved under a New Drug Application (NDA) or Marketing Authorization Application (MAA) and some contain active ingredients also marketed as prescription drugs.
- The Associate Director, Global Regulatory Affairs, will understand the Regulatory landscape for the portfolio of products within an assigned franchise(s), and manage Regulatory activities for areas of responsibility for marketed products and support and/or lead Regulatory strategy for innovative projects.
- The Associate Director will collaborate with colleagues in Legal, Medical, Marketing, and Operations in the development, review, and approval of packaging, labeling, and communication and promotional materials for new and existing products, provide guidance to project team members regarding regulatory compliance issues and be the primary contact with the US Food and Drug Administration (FDA) for assigned products.
- The candidate will be responsible for preparing meeting requests, meeting background packages and routine submissions to FDA.
- The incumbent will support and / or lead meetings and interactions with FDA taking into account the need to meet enterprise-wide objectives and maintain the Company’s reputation.
- The Associate Director will be responsible for Company Core Data sheet development for assigned products’ active ingredients, and SOP development/updates as required
- The Associate Director will champion behaviors that embody Our Credo and Core Values.
- The Associate Director will support our strategic and financial goals through focus, alignment and accountability.
- A minimum of a Bachelor’s Degree is required.
- An advanced degree (Masters, PhD, PharmD, MD, etc.) is preferred.
- A minimum of 10 years direct or indirect experience in Regulatory Affairs is required.
- Experience with clinical development programs, INDs, NDAs/sNDAs/ANDAs, monograph products and knowledge of the Rx-to-OTC switch process are required.
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.
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)