Global Regulatory Leader, Oncology (Senior Director) Job in Raritan, New Jersey US
Janssen Research Development, L.L.C., a member of Johnson Johnson's Family of Companies, is recruiting for a Senior Director, Global Regulatory Leader - Oncology. The preferred location for this position is Raritan, NJ, however this position can also be located in Spring House, PA, Titusville, NJ, or Los Angeles, CA.
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 Senior Director, Global Regulatory Leader - Oncology integrates multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified global regulatory strategies. This individual leads Global Regulatory Team(s) - activities and responsibilities will include, but are not limited to, the facilitation and coordination of team meetings, representation of Global Regulatory Affairs and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful product development globally and to provide input on governance recommendations. Ensures regulatory strategies throughout lifecycle of compounds as appropriate. Refines regulatory strategies as new data become available and re-assesses as necessary. Develops and updates contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile. Leads the preparation of regulatory dossiers for submission to Health Authorities. Leads Global Regulatory Team(s) to develop global marketing approval submission plans and timing, modifies submission plans and aligns with sourcing, Intellectual Property and launch strategies as appropriate. Establishes Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to Health Authorities. Works with the Global Regulatory Team to provide input for target labeling, and the Labeling Working Group in making strategic decisions, including the creation of Labeling strategy. As a member of the CDT, provides feedback to Discovery and other functions that may translate into potential new uses. Participates in and conducts licensing evaluations as needed. May manage a staff, including staff that supports additional portfolio products.
Qualifications
A Bachelor's degree in a scientific discipline and a minimum of 10 years of pharmaceutical industry or health authority experience is required. An Advanced degree (MS, PhD, MD or Pharm D) is strongly preferred. At least 6 years of RA or related experience is required. A minimum of 4 years experience within a supervisory capacity or managing teams within matrix environment is required. A wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities is required. Working knowledge of WW HA laws, regulations, guidance and global regulation submission routes available for new study drugs is required. Detailed understanding of competitors in the area and what they are doing in early/late development and knowledge of labeling aspects is required. Solid understanding of biology and chemistry relevant to the Oncology therapeutic area is required. A basic medical/scientific understanding of clinical trials is preferred. Experience developing regulatory strategies and an understanding of product development is required. Up to 20% international and domestic travel may be required for this position. The preferred location for this position is Raritan, NJ, however this position can also be located in Spring House, PA, Titusville, NJ, or Los Angeles, CA.
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