Regulatory Affairs Manager - CMC Job

Job description

Regulatory Affairs Manager
- CMC-000010XDDescriptionJanssen Research & Development, LLC, a Janssen Pharmaceutical Company of Johnson & Johnson, is currently recruiting for a Regulatory Affairs Manager
- CMC. This position will be located in Malvern, PA, Raritan, NJ or Leiden, The Netherlands.
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 visit http://www.
JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.
JanssenPharmaceuticalsInc.com for more information.
The Regulatory Affairs Manager
- CMC will contribute to the development of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies and submissions with a focus on approved drug substances and drug products. The Manager ensures that the regulatory strategy and submission content meet the global regulatory requirements over the lifecycle of the product. Ensures CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP). Assures connectivity to the overall global regulatory strategy through partnership and communication with Global Regulatory Affairs and Janssen Supply Chain. Participates as the Regulatory CMC Lead on CMC Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations. Refines regulatory strategies as new data become available. Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product. Prepares regulatory dossiers for submission to Health Authorities. Actively participates on Global Regulatory Team(s) to develop global marketing approval submission plans. The successful candidate will stay abreast of all pertinent global laws, regulations and guidances to provide accurate regulatory assessments of CMC changes to teams and executes regulatory planning and implementation.
QualificationsA minimum of a Bachelor's degree with 8+years OR MS degree with 6+ years OR Ph.
D. with 4+ years of relevant pharmaceutical industry experience is required. Prior Regulatory CMC experience including basic knowledge of worldwide regulatory requirements, US and EU Health Authority regulations and guidances is preferred. Experience developing regulatory strategies preferred and an understanding of product development required. Solid understanding of biology and chemistry is required. Experience with biological products (monoclonal antibodies or proteins) is preferred. Proficiency with the MS Office suite of products and data management tools is required. Excellent interpersonal, teamwork and verbal/written communication skills required. Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously required. Ability to communicate cross-functionally and cross-company and present and defend CMC management-approved regulatory strategy and opinion to project teams required. Ability to demonstrate model behavior, understand priorities and encourage others to drive for results required.
This position will be based in Malvern, PA, Raritan, NJ or Leiden, The Netherlands. This position may require approximately 10% travel, both International and Domestic.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Solid understanding of biology and chemistry relevant to monoclonal antibodies and proteins is preferred.
J2W:LIJ2W:BIOJ2W:RAPSPrimary Location:North America-United States-Pennsylvania-MalvernOther Locations:Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-RaritanOrganization: Janssen Research & Development, LLC. (6084)Job Function: Regulatory AffairsCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement