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Global Director, Regulatory Affairs
Requisition ID: 3126180206
Johnson & Johnson Consumer Inc. is currently recruiting for a Global Director, Regulatory Affairs, to be located at either Fort Washington, PA or Skillman, NJ location.
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 Group 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, Regulatory Affairs function and will report into the Senior Director, Regulatory Affairs. The Global Director, Regulatory Affairs (RA) will have Regulatory responsibility for the Analgesics portfolio including Tylenol®, Motrin® and several products in development (NPD) that include a wide range of Regulatory classifications (New Drug Applications (NDAs), Monograph Drugs, Medical Devices and combination products). The candidate will be the primary contact with the Food and Drug Administration (FDA) for Analgesic NDAs.
Responsibilities include but not limited to the following:
- Ensure appropriate and timely input to relevant proposed Guidelines, regulations and laws.
- Must be comfortable and effective in the role of Company spokesperson at trade association meetings, public hearings and Advisory Committee Meetings as well as with media, scientific meetings, and in interactions with other government agencies and staff.
- Provides the necessary leadership to enable strong regulatory strategies, impact assessments, and risk management plans that drive timely regulatory approvals, ensure continued access to marketed products, and that help drive achievement of business goals.
- Drives collaboration with global R&D, cross functional and business colleagues to develop robust yet innovative claims supported with sound science.
- Serves a critical role as regulatory counsel in determinations of regulatory risk for products and claims. This includes developing and managing credible relationships with health authorities.
- Will help drive understanding and commitments to goals and objectives and inspire employees to be part of a continued transformation.
- As a member of the JJCI (McNeil Healthcare Division) Regulatory Leadership Team, the Director will identify opportunities to strengthen the efficiency and effectiveness regional and the global regulatory organization.
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.
- A minimum of a Bachelor’s Degree is required. An advanced degree (Masters, PhD, PharmD, etc.) is preferred.
- A minimum of 10 years professional experience with 7 years of direct or indirect experience in Regulatory Affairs is required.
- Experience with clinical efficacy programs, INDs, NDAs/sNDAs, monograph products and knowledge of the Rx to OTC switch process and ANDAs is required.
- Experience with Devices and Cosmetics is desirable.
- Previous experience partnering with and managing teams within a matrix environment or projects outside of North America is required.
- A strong track record of achieving approvals and influencing FDA is critical/required.
- Experience working with industry counterparts and trade association committees and task groups is preferred.
- Regulatory Affairs Certification (RAC) is preferred.
- A minimum of 15% travel including to local sites in the area, as well as other locations based on business needs is required.
United States-Pennsylvania-Fort Washington
North America-United States-New Jersey-Skillman
J & J Consumer Inc. (6101)