- 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
- 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 (Summit, 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
- 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
- City of New York (New York, NY)
- …researcher, a clear and concise writer, a creative thinker, and a team player. The Associate 's work product must be of high quality , timely and well organized, ... Only candidates under consideration will be contacted. The Legal Associate (" Associate ") will report directly to, and...General Counsel and become an expert in the City's regulatory process and other legal issues that impact the… more
- City of New York (New York, NY)
- …and or support staff and will report to the Deputy General Counsel for Regulatory Affairs . Your Responsibilities: The Associate General Counsel Counsel's ... York City Department of Housing Preservation Development (HPD) promotes quality and affordability in the city's housing, and diversity...equitable growth. Your Team: Within HPD's Office of Legal Affairs , the Regulatory Affairs Division… 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
- 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
- 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
- Lilly (New York, NY)
- …Pharmacoeconomics/health outcomes, formulary management, technology assessment/value frameworks, quality measures, health policy expertise along with the ... + Stay abreast of emerging science, environmental trends, healthcare policy, and regulatory actions relevant to US population-based decision-makers + Serve as a… 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
- Merck (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Merck (Rahway, NJ)
- …strong relationships with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs , and external partners, ... identifying, assessing, and mitigating potential risks to ensure patient safety and product quality . + Ensure compliance with all regulatory requirements and … more
- AIG (New York, NY)
- Assistant General Counsel - Coverage Litigation (Casualty) AIG's Global Legal, Compliance, Regulatory and Government Affairs (GLCR) department is comprised of ... attorneys and other professionals providing high- quality advisory and transactional support with integrity and objectivity...send an email to ###@aig.com. Functional Area: LG - Legal, Regulatory & Gov't Affairs AIG Claims,… more