HireDiversity

Raritan, NJ, US

ASSOCIATE DIRECTOR, REGULATORY AFFAIRS - CMC-8916120703

Description

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs - CMC, located in Raritan or Titusville, NJ OR Spring House, PA OR Fremont, CA OR Beerse, Belgium.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Associate Director, Regulatory Affairs - CMC will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to support post-approval compounds. The Associate Director ensures the development strategy meets 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 Therapeutic Area Regulatory Affairs (Global Regulatory Leader). 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. 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. Assures a seamless transition of supported products from the Global CMC RA Pre Approval group. The position is also expected to act as a resource, when needed, for other Regulatory CMC RA roles such as Drug Substance support or Pre Approval activities.

Qualifications


A Bachelor's degree and a minimum of 10 years of overall experience including at least 7 years of relevant regulatory affairs and/or pharmaceutical industry experience OR a Master's degree and a minimum of 8 years of relevant regulatory affairs and/or pharmaceutical industry experience OR a PhD and a minimum of 6 years of relevant regulatory affairs and/or pharmaceutical industry experience is required. Prior pharmaceutical industry experience is preferred. Regulatory CMC or CMC experience is required. Drug development experience is preferred. A working knowledge of global HA laws, regulations, and guidance is preferred. Solid understanding of biology and chemistry relevant to a therapeutic area is preferred. Proficiency in the MS Office suite of products and data management tools 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. This individual will communicate cross-functionally and cross-company and present and defend CMC management-approved regulatory strategy and opinion to corporate project teams. The ability to demonstrate model behavior, understand priorities and encourage others to drive for results will be needed. This position can be located in Raritan or Titusville, NJ OR Spring House, PA OR Fremont, CA OR Beerse, Belgium.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-California-Fremont, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Research & Development, LLC. (6084)