Associate Director Global Regulatory Affairs (GRA) Diagnostics.
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Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate 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, or Rockville MD.
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 (http://www.janssenpharmaceuticalsinc.com)
The Associate Director Global Regulatory Affairs (GRA) Diagnostics (Dx) supports the Therapeutic Regulatory Leader, Global Regulatory Leader and/or Application Owner for regulatory activities for In Vitro Diagnostics (IVD), Software as a Medical Device or Wearable Devices in development and/or marketed pharmaceutical products by providing regulatory guidance and coordination to project teams.
Specifically for Companion Diagnostics: research regulatory approvals, guidance documents, and bridging requirements between Drug and IVD regulatory affairs and development teams.
Contributes to the development and realization of business, e.g. by contributing to the development of IVD and LDT regulatory strategies.
This function supports licensing of products developed by Janssen.
- Applying Dx expertise, helping 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 and may require the preparation and maintainence of 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 Manage and inform the project team 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 life-cycle from discovery to clinical trials to marketing is preferred.
- Knowledge of Health Authority (HA) organizational structure and HA processes for reviewing submissions is preferred
- Experience with companion diagnostics is preferred. 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 required
- 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
- Proven ability to work with minimal supervision 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 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-Maryland-Rockville, United States-New Jersey-Titusville, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)