Johnson & Johnson Careers
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Associate Regulatory Affairs Manager
Requisition ID: 9372180418
Johnson & Johnson Consumer Inc. a member of Johnson & Johnson’s Family of Companies, is currently recruiting for an Associate Regulatory Affairs Manager to be based out of 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. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
This position resides within the R&D organization, Global Regulatory Affairs function, and will report into the Director, Global Regulatory Affairs. The Associate Manager, Global Regulatory Affairs (RA) OTC will support key brands, that may include a range of Regulatory classifications.
In accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, this position provides support for key brands 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 and some contain active ingredients also marketed as prescription drugs.
- The Associate Manager, Global Regulatory Affairs, will understand the Regulatory landscape for the OTC portfolio, and manage Regulatory activities for areas of responsibility for marketed products and support and/or lead Regulatory strategy for innovative projects.
- The candidate will have responsibilities for relevant promotional review including digital media.
- The candidate will be responsible for routine submissions to FDA, preparing meeting requests and meeting background packages to FDA.
- The incumbent will support and /or lead meetings and interactions with FDA taking into account enterprise-wide objectives and that meeting objectives are met and the strong reputation of the Company is maintained.
- The Associate Manager will champion behaviors that embody Our Credo and Core Values.
- The Associate Manager 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, etc.) is preferred.
- A minimum of 6 years of business experience is required with 4 years of relevant Regulatory Affairs experience is required.
- Experience with clinical development programs, INDs, NDAs/sNDAs, is required and knowledge of the OTC drug monograph system, Rx-to-OTC switch process, and ANDAs is required.
- May be required to travel up to 15% including to local sites in the area, as well as other locations based on business needs.
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)