Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, North American Regulatory Leader, Immunology. The position will preferably be based in Spring House, PA, but flexible arrangements for other site locations can be negotiated.
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 Associate Director, North American Regulatory Leader, Immunology will:
• Responsible for the development, implementation and maintenance of North American regulatory strategies for both large and small molecules with indications targeted in areas of Rheumatology, Gastroenterology, and Dermatology.
• Key contributor on the Global Regulatory Team and on multiple cross-functional teams including but not limited to the Dossier Team, the Clinical Team, the Labeling Working Group, and the Global Strategy Team.
• Provides strategic direction to the teams and critical review of key FDA and Health Canada submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
• Developing regulatory strategies, interacting with Health Authority (HA) & operating companies, handling regulatory submissions, and providing regulatory input to other functions.
• Provide input on cross-functional teams such as the clinical team.
• Act as a back up to the Global Regulatory Liaison as appropriate.
• In interacting with the Health Authority, the NARL will lead and/or participate in meetings with FDA and Health Canada as appropriate.
• Prepare other company personnel for interactions with HA’s.
• Establish the NA content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
• Lead the regulatory response team for FDA and Health Canada questions.
• Manage routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities.
• Serves as a member of LWG to create or update USPI, participates in development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS to ensure that annotations are complete and correct.
• Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
• A minimum of a Bachelor’s degree is required.
• An advanced degree (MS, PhD, MD or Pharm D) is preferred.
• A minimum of 8 years of pharmaceutical experience with at least 6 years of regulatory experience is required.
• A scientific background/knowledge of biology & chemistry is required.
• Knowledge of FDA and Health Canada regulations and guidelines related to the product/project life cycle is required.
• Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
• A broad understanding and experience in drug development including early and late development is preferred.
• Previous experience in the Immunology therapeutic area is highly preferred.
• A broad understanding of lifecycle management is required.
• Knowledge of FDA structures & how that Agency operates; knowledge & understanding of commercial business needs; and understanding of scientific data (clinical & non-clinical) is required.
• Detailed knowledge of FDA laws, regulations, and guidance as they apply to regulatory submissions; understanding of documentation requirements; and the ability to review submission documents to determine whether they meet regulatory requirements, and are consistent with the regulatory strategy is required.
• Ability to work successfully within a team environment and as an individual contributor, project management skills, strong oral & written communication skills and organization & multi-tasking skills are required.
• Working knowledge of US labelling requirements is required.
• The position will preferably be based in Spring House, PA, but flexible arrangements for other site locations can be negotiated, and will be required to travel up to 10% domestic and internationally.
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J2W: LI NA
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
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