- Actalent (Bridgewater, NJ)
- Job Title: Head of Regulatory AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ. Reporting to the ... with the R&D, Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the ... Cosmetic listings, etc.), under the direct supervision of the Head of Quality / Regulatory . + Assist...Quality / Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US ... aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to...regard to ways or working or resources to the Head of US Regulatory Affairs … more
- Sanofi Group (Bridgewater, NJ)
- …a real impact on millions of patients around the world. The Global Medical Head of Rhinology and Gastroenterology (R&G) will report to the Global Medical Head ... commitment to achieve corporate objectives while maintaining the highest ethical, regulatory and scientific standards is required. **Job Responsibilities:** + Lead… more
- Novo Nordisk (Plainsboro, NJ)
- …Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Citigroup (New York, NY)
- …issue identification and comprehensive remediation Key Responsibilities Reporting directly to the Global Head of ORM, the responsibilities for the ORM Head for ... (not limited to) Chief Operating Office, Enterprise Services and Public Affairs , Citi Security and Investigative Services, Legal, Independent Risk Management, and… more
- Sanofi Group (Bridgewater, NJ)
- …you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable decision ... and externally as "one GRA voice" with TA, GBU Head and up to the GRA LT when needed...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global), in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs , Development Operations and Development Program Management, ... The Executive Director, Biostatistics (CDU-Biostatistics Head , Internal Medicine) leads the statistical team for...the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams… more
- Bristol Myers Squibb (Madison, NJ)
- …of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** . Lead safety activities and benefit-risk ... documents as well as safety sections of relevant clinical trial documents and regulatory filings. . Lead team in the evaluation & management of signals emerging… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the clinical… more
- Sanofi Group (Morristown, NJ)
- …work in close partnership with other departments including brand teams and Public Affairs + Play a leadership role in developing, executing, and contributing to the ... Roadmap (CMR) through close collaboration with the Franchise Medical Head as well as demonstrating active involvement in the...information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health… more
- Sanofi Group (Bridgewater, NJ)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... Pipeline Respiratory Medical Director reports to the Global Medical Head of Immunology and works under the direction of...required + Experience in pipeline, clinical development and/or medical affairs on a global or regional level including design… 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
- Sanofi Group (Bridgewater, NJ)
- …Collaborate with cross-functional teams, including but not limited to Sales, Marketing, Medical Affairs , Legal, and Regulatory Affairs , to ensure alignment ... Director of Marketing Operations to join our team. Reporting to the Head , North America, Go-to-Market Capabilities (GTMC). This individual will be responsible for… more
- Sanofi Group (Bridgewater, NJ)
- …into the Global Medical Immunology team that is part of the Medical Affairs Specialty Care organization. Our Medical function serves as a key strategic partner ... with commercial, regulatory , clinical, and market access on therapeutic solutions to...solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …CRO deliverables for contracted statistical services. + Provides statistical components of regulatory submissions. + Assists the Department Head in the ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Sanofi Group (Bridgewater, NJ)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of Immunology and works under the direction of the Global Respiratory… 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 ... maintaining a statistical programming infrastructure to ensure timely, high quality programming support to clinical development projects within designated… more
- SMBC (Jersey City, NJ)
- …lines with guidance and advice on relevant rules and regulations. The Regulatory Affairs department manages the regulator relationship, communication and ... interaction with US regulatory agencies. The US Financial Crime department is responsible...Officers, Risk Management, Operations, IT, and Legal; + Support Quality Assurance efforts within the Market Surveillance program; +… more
- AbbVie (Florham Park, NJ)
- …including Clinical Development Operations, Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs , to ensure the integration and accuracy ... the strategy for Oncology in collaboration with CDSO Therapeutic head TA and will also support the growth and...evaluations to ensure the highest level of productivity and quality . + Establish and maintain relationships with external vendors,… more