Johnson & Johnson Careers
Manager, North American Regulatory Scientist, Immunology
Requisition ID: 1665180910
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:
- Provide support to the North American Regulatory Leader (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.
- Support all regulatory activities associated with the development, post-approval and life-cycle management for designated products.
- Support the creation of regulatory documents by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate.
- Provide guidance and support to product development teams on regulatory issues.
- Act as back-up for contact with FDA as needed; assist in the preparation for meetings with FDA and responses to Health Authority quires; review clinical trial plans and protocols and ensure alignment with regulatory requirements and global regulatory strategy.
- Develop an understanding of the North American regulatory environment, competitor intelligence and therapeutic area.
- Review and approve submission plans to ensure compliance with regulatory requirements and liaise with Submission Management.
- Provide other general support on an as needed basis e.g. provide regulatory input and follow-up for inspections, audits, and litigation support and products complaints (as appropriate).
- Contributes to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results.
- Typically has responsibility for smaller scope projects and participate in multi-functional projects.
• A minimum of a Bachelor’s Degree with 5+ years (or an
advanced degree with 4+ years) of relevant industry experience is required.
• A degree in a scientific or technical discipline 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.
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-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)