Manager, Global CMC Regulatory Affairs (1 of 3)

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Manager, Global CMC Regulatory Affairs - to be based in Titusville, NJ, Raritan, NJ, Spring House, PA or LaJolla, CA.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visithttp://www.JanssenRnD.comfor more information.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Infectious Disease and Vaccines, Metabolic, Neuroscience and Immunology. Please visit www.JanssenPharmaceuticalsInc.com for more information.

The Manager, Global CMC Regulatory Affairs will contribute to the development of global Chemistry, Manufacturing and Control (CMC)regulatory strategies, primarily for a portfolio of small molecules.

The primary responsibility is to support both post- and pre-approval products. The Manager, Global CMC Regulatory Affairs will interact as necessary with the CMC and/or Value Stream Teams, cross-functional technical teams, local J&J operating companies and other business partners.

Responsibilities include authoring and review of global submissions, responding to worldwide Health Authority requests, providing regulatory assessment of proposed CMC changes, as well as providing strategic regulatory advice and review of development plans and submissions for assigned projects. Responsibilities will also include interaction with worldwide Health Authorities.

This position will be a flexible resource and may be used for other CMC RA Regulatory roles as needed.

The Manager, Global CMC Regulatory Affairs will stay abreast of all pertinent global laws, regulations and guidances to provide input on regional regulatory strategies and implementation activities.

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.

Qualifications

  • A minimum of a Bachelor's degree and 8 or more years of relevant pharmaceutical industry experience within chemistry pharmacy disciplines.
  • CMC regulatory experience is required.
  • Basic knowledge of regulatory requirements is required.
  • Drug development experience is preferred.
  • Working knowledge of global HA laws, regulations, and guidance's is required.
  • Experience developing regulatory strategies is preferred.
  • Solid understanding of biology and chemistry is preferred.
  • Demonstrated ability to communicate regulatory requirements is required.
  • Excellent interpersonal, teamwork, and verbal/written communication skills will be needed.
  • Good organizational skills and the ability to manage multiple tasks/projects/priorities and complex systems simultaneously will be needed.
  • The ability to communicate cross-functionally and cross-company as well as present and defend CMC management-approved regulatory strategy to corporate project teams is necessary.


Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Regulatory Affairs
Requisition ID
9710180115


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