Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, North American Regulatory Scientist, Immunology. The position will be based in Spring House, PA.
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 Manager, North American Regulatory Scientist, Immunology will:
• Provides support to the North American Regulatory Liaison (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy.
• Participation in global regulatory team meetings as appropriate.
• Advising the regulatory team on applicable regulatory requirements, and project-specific regulatory issues as assigned.
• Developing an understanding of the North American regulatory environment, competitor intelligence and therapeutic area.
• Act as back-up for contact with FDA as needed; draft cover letters for FDA communications; assist in the preparation of meetings with FDA; assist in development and improvement of processes related to regulatory submissions; and review clinical trial plans and protocols and ensure alignment with regulatory requirements.
• Provide regulatory support throughout registration process and life-cycle management.
• Advise team in required documents and submission strategies.
• Assist with timely availability of submission documents, ensure that all document components are in place on time.
• Draft and review some document content (depending on level of regulatory knowledge/expertise).
• Prepare, hold and lead cross functional team meetings as appropriate.
• Understand submission details and liaise with Submission Management.
• Review and approve submission plans to ensure compliance with regulatory requirements.
• A minimum of a Bachelor’s Degree with 6+ years of relevant industry experience is required.
• An advanced degree (MS, PharmD or PhD) is preferred.
• Understanding of the drug development process and regulatory submission and approval process and knowledge of the regulatory environment, guidelines and practices of the US FDA is required.
• Previous experience in the Immunology therapeutic area is highly preferred.
• 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.
• This position is located in Spring House, PA and may require up to 10% domestic and international travel.
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J2W: LI NA
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
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