- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the ... of the Head of Quality / Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Novo Nordisk (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Novo Nordisk (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Merck (Rahway, NJ)
- …reliable, and compliant medical products, practices and solutions to the world. The Associate Principal Scientist Regulatory Affairs supports products in the ... **Job Description** Our Regulatory Affairs team brings new medical...in preparing submissions, protocol review, and conducting research on regulatory guidances or competitive intelligence. The Associate … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Veterans Affairs, Veterans Health Administration (Lyons, NJ)
- …Program Director. Maintains knowledge and ensures compliance with all regulatory and accreditation standards, directives, policies, and standard operating procedures ... culturally competent care and promotes a culture of accountability for high- quality , cost-effective outcomes. Contributes to the development of care delivery models… more
- Bristol Myers Squibb (Princeton, NJ)
- …and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality Management Systems training elements **Qualifications ... + Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance… more
- RWJBarnabas Health (Somerset, NJ)
- …should be in a closely related field such as health/business administration, regulatory compliance, accreditation or licensure associate , business development or ... Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498.../ Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health Corporate Services Department:External Affairs and Policy Location: SBC Corporation, Somerset, Somerset, NJ… 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
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research ... **Job title** : GRA Device Lead ( Associate Director) **Location:** Cambridge. MA **,** Morristown, NJ...key stakeholders including clinical, medical affairs , Industrial Affairs (Device Development, manufacturing, quality , supply chain)… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... is required. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance, etc.) is required.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …MTPA. + Liaise with other internal partners, eg: Biostatistics, Clinical Operations, Safety, Quality Assurance, Regulatory Affairs and external partners, eg: ... project teams to ensure that projects/studies are performed with a high quality to support submissions to regulatory authorities. + Negotiate responsibilities… more
- Bristol Myers Squibb (Princeton, NJ)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:**… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Senior Director, Patent, you'll collaborate with cross-functional teams, including R&D, regulatory affairs , and portfolio management, to ensure the successful ... Associate Director, Patent - Parsippany, NJ Date: Feb...manufacturing site, device, and API considerations. + Collaborating with Regulatory Affairs to prepare ANDA submissions, patent… more
- Ascendis Pharma (Princeton, NJ)
- …enterprise risk, escalation, and resolution while collaborating and integrating with Compliance, Regulatory , and other functions. The Associate General Counsel - ... the business on complex legal issues and processes. The Associate General Counsel - US Commercial and Medical is...support and review of materials for commercial and medical affairs activities on risk assessments. Contributing to a comprehensive… more
- Actalent (Morristown, NJ)
- …client's commercial business and works closely with Supply Chain, Project Management, Regulatory Affairs , R&D, and external suppliers and partners. The position ... Job Title: QA AssociateJob Description The QA Associate Operations of 3rd Party Quality reports to the Sr. Director, 3rd Party US Quality . This position… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to ... on real-world evidence, and creating hope for all facing illness. The Associate Director, Biostatistics is responsible for providing statistical support to clinical… more
- Sanofi Group (Morristown, NJ)
- …+ **Cross-Functional Collaboration** - Collaborate with internal stakeholders (R&D, regulatory , safety, medical affairs , commercial) to drive switch-related ... global medical strategies for Rx-to-OTC switch programs, collaborating with science, regulatory , and commercial teams to ensure alignment. + **External Expert… more