Associate Manager, Regulatory Affairs

24 Apr, 2022

Jobs

Associate Manager, Regulatory Affairs

Johnson & Johnson
Ft. Washington, PA

Job Description

Johnson & Johnson Consumer is recruiting for an Associate Manager, Regulatory Affairs to be located in Fort Washington, PA or Markham, Canada.

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 LISTERINE®. 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.

In this role, you will manage/develop the successful coordination, compilation, submission, approval, and maintenance of applications for both OTC drug and skin health products in NA. Your scope may also include development and submission of dossiers for global dossiers and other regulatory responsibilities as required. You will help drive the success of the OTC launches in NA and globally!

Key Responsibilities:

  • This position will work closely with cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval.
  • This position will execute CMC and Franchise regulatory strategies with internal research and development, and other technical/scientific colleagues.
  • You will collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings.
  • This position provides direction regarding the regulatory requirements of new and marketed OTC and Skin Health products, as well as helping support the implementation of long term companywide regulatory strategies and operating principles/practices.

Qualifications

Education:

  • A minimum of a Bachelor’s degree in relevant health-related scientific discipline is required or an advanced degree in a related field is required.

Experience And Skills:

Required:

  • A minimum of 3 years of OTC CMC/RA and related experience in the Rx/OTC environment including experience with eCTD submissions for NDA/NDS products is required.
  • Knowledge/familiarity with Health Canada/FDA and Global regulatory registration of drugs is required.
  • Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment are required.

Preferred:

  • Regulatory Affairs Certification (RAC) preferred.
  • Broad regulatory affairs experience is preferred.
  • Experience interacting with health authorities is preferred.
  • Experience interacting with relevant trade associations or serving on trade association committees is preferred.

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 eAccmployment 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, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, 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. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

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.

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.

Learn more about this position here

Job posted: 2022-04-24