.Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs, supporting programs in the Immunology Therapeutic Area. This position is to be located in Titusville, NJ; Raritan, NJ; Spring House, PA; or La Jolla, CA (hybridrole).The Associate Director, Regulatory Affairs will be responsible for the development, implementation, and maintenance of North America regulatory strategies for compounds in the Immunology Therapeutic Area.Key Responsibilities: Responsible for the development and implementation of robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.Leads and facilitates cross-functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams.Provides regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.Serves as primary contact with Health Authorities (HA) &/or Operating Companies.Lead and/or participate in meetings with regulatory agencies as appropriate.Prepare company personnel for interactions with HA.Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.Lead and oversee the preparation of dossier content for INDs, BLA/NDA according to the strategic plan for the region and health authority commitments.Perform critical review of submission documents to ensure compliance with regulatory requirements.Participate in development of labeling negotiation strategies.Provide input into strategy with respect to clinical study design.Negotiate and manage regional post-approval commitments.Maintain an understanding of the competitive landscape, e.G., views of HAs, regulatory precedents, labeling differences and disease area-specific issues.Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge.Provide input to Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate.Qualifications: A Bachelor's degree and at least 8 years of health regulated industry experience, or an advanced degree (MS/PharmD or PhD) and a minimum of 6 years of health regulated industry experience.An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.Therapeutic area experience in autoimmune diseases is beneficial.Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.Understanding of the regulatory submission and approval process is required.Previous experience interacting with health authorities is required.Experience critically reviewing and compiling regulatory documents is required
