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Associate Manager Regulatory Affairs

Johnson & Johnson

Cutting-edge science, digital technology, and new ways of thinking are improving how people are cared for around the world, and Johnson & Johnson is at the forefront.

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; Skillman, NJ; or Clearwater, Fl. Position will support a hybrid working environment, 3 days per week in-office out of one of the aforementioned locations.

Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world’s largest consumer health and personal care products company. Our consumer companies produce many of the world’s most trusted brands, among them JOHNSON’S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and ZYRTEC®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

This position resides within the R&D organization, Regulatory Affairs function, and will report into the Associate Director, Regulatory Affairs. The Associate Manager, Regulatory Affairs will have regulatory responsibility for the Cough/Cold franchise, which includes marketed products, and products in development, regulated under multiple Regulatory classifications (NDA/ANDA and Monograph Drugs).

  • The company operates in a highly regulated business environment. Many of the products in the Over-the-Counter (OTC) portfolio are approved under an NDA or ANDA, and some contain active ingredients also marketed as prescription drugs.
  • The Associate Manager, 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 within a regulated industry) or an advanced degree (Masters, PhD, PharmD, etc.) is required.
  • Knowledge of INDs, NDAs, and 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 announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Pennsylvania-Fort Washington-7050 Camp Hill Road
Other Locations
North America-United States-New Jersey-Skillman, North America-United States-Florida-Clearwater
Organization
Johnson & Johnson Consumer Inc. (6101)
Job Function
Regulatory Affairs
Requisition ID
2206045391W

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Associate Manager Regulatory Affairs

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Johnson & Johnson

Cutting-edge science, digital technology, and new ways of thinking are improving how people are cared for around the world, and Johnson & Johnson is at the forefront.

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