- Pulmovant (New York, NY)
- …each meticulously tailored to address a specific medical need. Summary The Head of Regulatory Affairs and Quality is responsible for leading the global ... member to the company's senior management team, managing activities across the regulatory affairs and quality assurance and control organization (GxP). Key… more
- Englewood Lab, Inc (Totowa, NJ)
- …+ Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. + With the assistance of Head of R&D (or designee), create ... 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
- Pfizer (New York, NY)
- …and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs ... of the international markets within the GRS organization. The Head of GRS International Regulatory Sciences must...the GRS functions across regions and ensure that all regulatory deliverables are of high quality and… more
- Englewood Lab, Inc (Totowa, NJ)
- …and document submissions to regulatory agencies under the direct supervision of the Head of Quality . + Assist the Manager during periodic regulatory ... designated regulatory filings and proposed submissions. Notify heads of quality and R&D (or designee) regarding any discrepancies or deficiencies with filings… more
- Sanofi Group (Bridgewater, NJ)
- …in ensuring appropriate review and approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... **Job title:** US Medical, Head of Oncology, North America Specialty Care **Location**...and you'll provide inspirational leadership to the Oncology Medical Affairs teams to assure delivery of key strategies and… 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
- Citigroup (New York, NY)
- The Head of Functions Technology will partner to define and deliver Technology Strategy to ensure continued improvement of Global Functions platforms across the Firm ... infrastructure for Enterprise Risk, Compliance, Controls, Enterprise Services and Public Affairs (ESPA), Citi Realty Services (CRS), Human Resources (HR), Legal,… 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
- 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 (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
- 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
- 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
- AIG (New York, NY)
- …Legal team is comprised of attorneys and other para-professionals providing high quality advisory, transactional and regulatory support across the Company. This ... business initiatives. This position ultimately reports to the Global Head of Underwriting and Reinsurance Legal within AIG's legal...email to ###@aig.com . Functional Area: LG - Legal, Regulatory & Gov't Affairs Estimated Travel Percentage… more
- Sanofi Group (Bridgewater, NJ)
- …collaborative and innovative medical team of dedicated to delivering the highest quality of evidence through innovative science to finalize the development and to ... new vaccine candidate. The incumbent will report to the Global Medical Franchise Head , who has delegated coordination of daily activities to the ExPEC Franchise… 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
- 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
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of statistical programming to clinical project teams, and managing CROs, implementing quality control process. Individual must have solid SAS Programing skills and ... statistical programing support for early and late-phase clinical development and medical affairs studies including analyzing data. This position is for a flexible,… more
- City National Bank (New York, NY)
- …projects and directs staff in providing maximum services in terms of quality and quantity within the specified budget and applications and product evaluations ... + Directs, manages and maintains data processing and/or systems and ensures the quality of work performed and accuracy of output; manages systems projects to meet… more
