Johnson & Johnson Careers

Associate Manager, Regulatory Affairs (1 of 2)

Fort Washington, Pennsylvania
Regulatory Affairs


Job Description

Requisition ID: 4526190125

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 Over-the-Counter (OTC) products.


This position resides within the R&D organization, Global Regulatory Affairs function, and will report into the Associate Director, Global Regulatory Affairs. The Associate Manager, Global Regulatory Affairs 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 or 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 NDA or MAA, 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, and will be responsible for labeling review and approval.
  • The candidate will be responsible for routine submissions to FDA, preparing meeting requests and meeting background packages to FDA.
  • The candidate will support and /or lead meetings and interactions with FDA taking into account enterprise-wide objectives and ensure 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.


Qualifications
  • A minimum of a Bachelor’s Degree is required (science or in allied health preferred).
  • A minimum of 2 years of experience in Regulatory Affairs or an advanced degree (Masters, PhD, PharmD, etc.) is required.
  • Experience with INDs, NDAs, and knowledge of OTC monograph products and a basic understanding of the Rx-to-OTC switch process and ANDAs is required.
  • Experience in developing and executing Regulatory strategies is preferred.
  • Experience working with cross-functional teams including Marketing, Sales, Medical, Legal, Labeling and Quality Assurance is preferred.
  • Excellent communication, collaboration, and leadership skills.
  • Ability to interact with all internal departments and at all company levels, and with sister companies within J&J Consumer and across company sectors; as well as with local, state and federal regulatory agencies, industry partners, contractors and service providers.
  • This job will be located in Fort Washington, PA and may require travel up to 15%  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.



Primary Location
United States-Pennsylvania-Fort Washington-
Organization
J & J Consumer Inc. (6101)
Job Function
Regulatory Affairs
Requisition ID
4526190125