Associate Director, NA Regulatory Liaison
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Janssen Research & Development, LLC is recruiting for an Associate Director, NA Regulatory Liaison. The preferred located is Raritan, New Jersey however Springhouse, Pennsylvania, is acceptable.
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.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director, NA Regulatory Liaison 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 Associate Director, NA Regulatory Liaison 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, mentorship and guidance to direct reports (if applicable).
The Key Responsibilities of the Associate Director, NA Regulatory Liaison include:
• Participates in project related global regulatory team meetings by providing regional input.
• Builds 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.
• Determines timing, appropriate NA regional strategy and content for all HA meetings within the context of the global strategy.
• 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.
• Builds positive relationships and 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.
• Serves as member of the Labeling Working Group (LWG) to derive and update proposed CCDS/USPI based on target labels.
• Participates in building the 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.
• Supplies input on study design, conduct, and need for any additional studies.
• Provides input into risk/benefit assessment.
• Provides input to medical affairs programs.
• Creates strong interpersonal relationships partnering with cross-functional team members and positively deliver on people management and resource planning responsibilities.
• A Bachelor's degree and at least 9 years of health regulated industry experience, or an advanced degree and a minimum of 7 years of health regulated industry experience.
• At least 5 years of relevant regulatory affairs experience is required.
• An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
• Knowledge of HA organizational structure and HA processes for reviewing submissions is required
• Experience with companion diagnostics, combination products and/or biomarker development is preferred,
• Therapeutic area experience in oncology is preferred.
• Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
• The ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• The willingness and ability to be located in either Raritan, NJ or Springhouse, PA is required
• 10% domestic travel and potential international travel will be required for this position.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)