Johnson & Johnson Careers
Associate Manager, Regulatory Affairs
Requisition ID: 4877180731
Johnson & Johnson Consumer Inc. is currently recruiting for an Associate Manager, 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 Director, Regulatory Affairs. The Associate Manager, Regulatory Affairs (RA) will have regulatory responsibility for Medical Devices across need-states and the Digestive Health Franchise which includes key brands such as IMODIUM® A-D, PEPCID®, Lactaid®, and a number of products in development (NPD) that include a wide range of Regulatory classifications (NDAs and Monograph Drugs, Foods, Dietary Supplements, Medical Devices and Combination products). The candidate will be the primary contact with the Food and Drug Administration for digestive health NDAs and medical device submissions.
Additional responsibilities to include but not limited to the following:
- In being a key Subject Matter Expert in regulatory affairs for medical device across need-state, the candidate will provide strategic regulatory guidance to Engineering, R&D, and Marketing for filing strategy, minimum product requirements, regulatory testing requirements (electrical safety, software, mobile apps, etc.), risk management, labeling, review/approval of change control, and advertising & promotional claims for new product development.
- File Pre-Submission packages, 510(k) Premarket Notifications, and lead FDA interactions for medical devices. Submission work includes, but is not limited to authoring, reviewing, editing, and coordination of cross-functional review/feedback.
- Support external innovation due diligence activities and product development.
- Monitor regulatory environment for new industry standards, FDA guidance, regulation, and draft legislation for impact to the business. Work with industry association(s) to provide comment to draft guidance to shape regulatory policy.
- Support the execution of the sector Unique Device Identification (UDI) initiative.
- Collaborate with colleagues in Legal, Medical Affairs, Marketing, Project Management, Global Strategic Insights and Analytics, Supply Chain, & Quality and Operations in the development, review, and approval of packaging, labeling, and promotional materials (including digital assets) for new and existing OTC drug products.
- Responsible for all activities associated with the submission, approval, and maintenance of products to Health Authorities (NDA Prior Approval Supplements, Meeting Requests, Annual Reports, etc.), which includes, but is not limited to authoring, reviewing, editing, and coordinating cross-functional review/feedback; Company Core Data sheet development for assigned OTC active ingredients; SOP development/updates as required; provide guidance to project team members regarding regulatory compliance issues.
- Johnson & Johnson Consumer Inc., operates in a highly-regulated businesses environment. The Regulatory Affairs Associate Manager will champion behaviors that embody Our Credo.
- A minimum of Bachelor's degree is required. An advanced degree in relevant business or health-related scientific discipline is preferred.
- A minimum 6 years of direct or indirect Regulatory Affairs in a highly regulated environment is required.
- Experience with Class II medical devices required. Familiarity of drug development and OTC drug (monograph and NDA products) is preferred.
- History of successfully contributing to or leading product submissions and meetings with Health Authorities is preferred.
- Demonstrated understanding of Design Control and ISO 14971 is required.
- Knowledge of current FDA regulations, guidelines and their application to medical device is required.
- Knowledge of global health authority regulations for devices is preferred.
- Strong track record of partnering with cross-functional teams including Business Development, Marketing, and Engineering, with a demonstrated ability to combine research in regulations, precedent, and product design to develop and execute regulatory approval and claims strategies.
- Up to 15% domestic and international travel will also be required based upon business needs is 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
North America-United States-New Jersey-Skillman
J & J Consumer Inc. (6101)