Johnson & Johnson Careers
Associate Director, North American Regulatory Leader
Requisition ID: 0259180821
Johnson & Johnson Pharmaceutical Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, North American Regulatory Leader, to be located in Raritan, NJ or Spring House, Pennsylvania.
Johnson & Johnson Pharmaceutical 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 NA Regulatory Leader participates in the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) if requested. Provides strategic input into the GRT for North America (NA). Leads and facilitates cross functional activities related to regional strategy. Serves as primary contact with North American Health Authorities (HA) &/or Operating Companies.
The NA Regulatory Leader leads and oversees the preparation of dossier content according to the strategic plan for the region and health authority commitments. May also contribute to preparations for dossiers for other regions. Works with the GRT to develop global marketing approval submission plan and timing. Serves as a member of Labeling Working Group (LWG) to derive and update proposed Company Core Data Sheet (CCDS) and US Package Insert (USPI) based on target label. Participates in development of labeling negotiation strategies. Negotiates regional labeling with HAs, going through each of the back-up strategies if necessary. Identifies resources required for implementation of the Regulatory Functional Plan for the region and provides line management, coaching and guidance to direct reports (if applicable).
- The NA Regulatory Leader participates in project related global regulatory team meetings by providing regional input.
- Develops and implements North American regulatory strategy.
- Refines regional regulatory strategy as new data becomes available and re-assesses as necessary.
- Provides input on implications for regulatory strategy through participation in other product-related teams (e.g., Dossier submission teams, Clinical and Labeling working groups).
- Provides input into strategy with respect to clinical study design.
- Develops and updates contingency plans for regulatory strategies.
- Reviews and provides regulatory input on regional Investigator Initiated Proposals.
- Acts as back-up to Global Regulatory Leader (GRL) upon request.
- Within the context of the global strategy, determines timing, appropriate NA regional strategy and content for all HA meetings.
- Works with regulatory agencies on a daily basis and leads and/or participates in other meetings with NA regulatory agencies as appropriate.
- Prepares company personnel for interactions with HA.
- Interacts with local NA commercial operating companies on individual products / processes.
- Contributes to preparations for Common Technical Document (CTD).
- Works with the GRT to develop global marketing approval submission plan and timing.
- Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
- Defines, generates, and submits appropriate data-driven responses to NA regional HA questions.
- Negotiates and manages NA regional post-approval commitments.
- Manages Adverse Experience (AE) safety reporting.
- Provides input to Submission Team to define submission plans including timing for new IND/CTA or IND/CTA amendments and HA reporting requirements; IND/CTA submission dossier content, scope and timing. Manages lifecycle management submissions (including safety reports).
- Provides input to and reviews submission documents to ensure they accurately answer the questions being posed and are consistent with HA commitments.
- Reviews labeling to ensure adequate documentation supports the regional labeling text. Approves submissions before dispatching to regulatory authorities.
- This individual serves as member of the Labeling Working Group (LWG) to derive and update proposed CCDS/USPI based on target labels.
- Participates in development of labeling negotiation strategies and development of supporting documentation for labeling.
- Negotiates regional labeling with HAs, going through each of the back-up strategies if necessary.
- Provides input for Target Label.
- A minimum of Bachelor’s degree is required.
- An advanced degree is strongly preferred.
- A minimum of 8 years of professional experience is required.
- A minimum of 6 years relevant regulatory experience is required.
- Experience within the oncology therapeutic area is preferred.
- Understanding of biology and chemistry is preferred.
- Experience developing regulatory strategies for both biologics and small molecules across multiple indications in the oncology therapeutic area is strongly preferred.
- Strategic experience in all phases of product development from pre-clinical to post-approval is preferred.
- Regulatory interface experience with the FDA is required.
- Working knowledge of US regulations and guidance and regulatory routes available for the study of new drugs is preferred.
- The ability to work in a matrixed environment with multiple stakeholders is strongly preferred.
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.
United States-New Jersey-Raritan
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)