- Novo Nordisk (Princeton, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Regulatory Affairs Operations Manager , is responsible for overseeing ... ensuring timely completion and adherence to objectives. The Operations Manager will work directly with the VP of Global... will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth… more
- Philips (Hamilton, NJ)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC ... entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory … more
- Philips (Malvern, PA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... and regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with Internal Stakeholders and collaborate with… more
- Penn Medicine (Plainsboro, NJ)
- …employees shape our future each day. Are you living your life's work? The Regulatory Affairs Manager is responsible to assist with organization-wide ... Medicare Services, NJ Department of Health, The Joint Commission (TJC), and others regulatory bodies. The Manager maintains current knowledge of standards and… more
- Novo Nordisk (Plainsboro, NJ)
- …required documents to FDA. Relationships The fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... Are you ready to make a difference? The Position The Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program based… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus +… more
- Bausch Health (Bridgewater, NJ)
- …the processes of booth activities + Works cross-functionally with other Medical Affairs , Regulatory , Pharmacovigilance matrix team members, as necessary + ... values drive our collective progress and impact. The Medical Information Manager will effectively communicate accurate, scientific, and balanced medical information… more
- Jewish Federation of Southern NJ (Cherry Hill, NJ)
- The Government Affairs Manager will advocate for the Jewish community of Southern New Jersey with elected officials by building key relationships and ... other opportunities systemwide. Job Responsibilities: + Develop and execute government affairs strategies to promote the Jewish Federation's goals and objectives. +… more
- Abbott (Princeton, NJ)
- …scientific dissemination of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global ... of ad promo materials or other assets which require medical/legal/ regulatory review + Organization & moderation of periodic Medical...Leadership Team + Supporting the Director of Global Scientific Affairs , in conjunction with the Sr. Manager … more
- University of Pennsylvania (Philadelphia, PA)
- … regulatory tracking systems; Developing, organizing, and maintaining all regulatory affairs documentation/files as required including training documentation, ... adverse events, and reportable events; Develop, organize, and maintain all regulatory affairs documentation/files as required including training, CVs, licenses,… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Ascendis Pharma (Princeton, NJ)
- …Medical - Endocrine Medical Affairs will report to the US General Manager with primary responsibility to lead the US Medical Directors and ensure the compliant ... Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs... Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more
- University of Pennsylvania (Philadelphia, PA)
- …resources, and much more. Posted Job Title Quality Assurance Specialist ( Regulatory ) CVPF(Center for Cellular Immunotherapy) Job Profile Title Research Coordinator ... issuance and external audits, DFPs, CAPAs review. + Assisting Manager as needed to help with raw materials release,...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …thorough knowledge of Federal Regulations, GCP and IND/IDE in research. Must understand regulatory affairs and their applications to Quality Control and Quality ... ACCELERATE natural history registry and biobank studies. The Program Manager will ensure that the protocols, SOPs, regulatory...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more