Johnson & Johnson Careers
Director Global Regulatory Affairs (GRA) Diagnostics
Raritan, New Jersey; Boston, Massachusetts; Horsham, Pennsylvania; Washington, District of Columbia; Jacksonville, Florida; Rockville, Maryland; Titusville, New Jersey; Spring House, Pennsylvania
Requisition ID: 5341190522
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Global Regulatory Affairs (GRA) Diagnostics. The position will be based at any one of the following locations; Raritan, NJ, Titusville, NJ, Horsham PA, Springhouse, PA, Boston MA, Washington DC, Rockville MD, Jacksonville FL
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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), Oncology, Immunology, and Infectious Disease. 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
The Director Global Regulatory Affairs (GRA) Diagnostics (Dx) develops the regulatory strategy, manages coordination with Dx development partners and leads worldwide submission of (new) In-Vitro Diagnostics (IVD) and Medical Devices (MD) to the regulatory agencies.
For people managers: Manages and motivates staff to ensure success in support of business goals.
Specifically for Companion Diagnostics: bridges requirements between Drug and IVD regulatory affairs and development teams.
Contributes to the development and realization of business, e.g. by development of adequate regulatory strategies.
This function supports licensing of products developed by Janssen.
• Applying Dx expertise, build regulatory strategy for the company’s in-vitro diagnostic devices and medical devices and global strategy and expertise for diagnostics identified by Janssen Therapeutic areas. The diagnostics can include complementary and companion diagnostics. Prepare and maintain the regulatory (submission) documents, e.g. 510(k)- & PMA-files, CE Technical documentation/design dossier, IDEs, Pre-Submission packages, amendments, etc.
• In particular for companion diagnostics or companion medical devices, provide regulatory support to the Therapeutic Global Regulatory Leader for devices in development and/or marketed products in the assigned portfolio within the therapeutic areas. Lead Regulatory person for partnering with diagnostic partners for successful regulatory approvals of companion and complementary diagnostics and medical devices (including medical mobile apps and digital devices).
• Keep abreast of current and pending approvals in specific therapeutic/ companion diagnostic/ medical device areas and be knowledgeable of laws, directives, guidance(s) and requirements related to those areas.
• Through Regulatory intelligence gathering and collaborating with GRA Dx team members, provide assessments of the impact of new and changing regulations on the company objectives to the management team.
To be successful in the role, you will have the following experience and skills:
• A Bachelor's degree and at least 10 years of health regulated industry experience is required
• An advanced degree is preferred
• An understanding of the drug product lifecycle from discovery to clinical trials to marketing is preferred.
• Knowledge of Health Authority (HA) organizational structure and HA processes for reviewing submissions is required
• Experience with companion diagnostics is required
• Experience with biomarker development is preferred,
• Therapeutic area experience in oncology is preferred.
• Thorough knowledge of global regulations for In Vitro Diagnostics or Medical Devices is preferred.
• Familiar with GCP, GLP, and clinical laboratory regulations and licensing is required
• Good knowledge of registration files for In Vitro Diagnostics and/or Medical Devices is preferred.
• Specific regulatory knowledge of digital medical device requirements, use in clinical trials, and registration is preferred.
• RAC certification is preferred
• A proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
• A proven ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• The willingness and ability to be located in either Raritan, NJ, Titusville, NJ, Horsham PA, Springhouse, PA, Boston MA, Washington DC, Rockville MD, Jacksonville FL is required
• 25% 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.
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United States-New Jersey-Raritan-
North America-United States-Massachusetts-Boston, United States-Pennsylvania-Horsham, United States-District of Columbia-Washington, United States-Florida-Jacksonville, United States-Maryland-Rockville, United States-New Jersey-Titusville, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)