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Senior Regulatory Affairs Associate
Requisition ID: 5003180302
Johnson & Johnson Consumer, Inc, a member of Johnson & Johnson’s Family of Companies, is currently recruiting for a Senior Regulatory Affairs Associate 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, Regulatory Affairs function and will report into the Director, Regulatory Affairs. The Senior Associate, 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 (NDA and Monograph Drugs, Dietary Supplements, Medical Devices, combination products).
- The Senior Associate, 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 company operates in a highly regulated business environment. Many of the products in the OTC portfolio are approved under an NDA (New Drug Application) and some contain active ingredients also marketed as prescription drugs.
- The incumbent will support and /or lead meetings and interactions with FDA taking into account enterprise-wide objectives, ensuring that meeting objectives are met and that the strong reputation of the Company is maintained.
- The Senior Associate will champion behaviors that embody Our Credo and Core Values.
- They 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 2 years direct or indirect experience in Regulatory Affairs is required.
- Experience with, INDs, NDAs, and knowledge of OTC monograph products the Rx-to-OTC switch process and ANDAs is required.
- Must be able to travel a minimum 15% including to local sites in the area, as well as other locations based on business needs.
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)