- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs , Regulatory Strategy to be a part of our ... Global Regulatory Affairs organization.In this role, you will...new indications. You will act as contact person with FDA and provide regulatory expertise and guidance… more
- Genmab (Plainsboro, NJ)
- … Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (eg FDA , EMA) A broad knowledge of life-cycle ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the...regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory affairs , Patient Safety ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Tris Pharma (Monmouth Junction, NJ)
- …working knowledge of regulatory and industry standards related to Medical Affairs role including Food and Drug Administration ( FDA ), Office of Inspector ... for scientific exchange with prioritized stakeholders in support of Medical Affairs strategiesCoordinates MSL support for clinical activities and… more
- Novo Nordisk Inc. (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… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory... FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee… more
- Mount Sinai Health System (New York, NY)
- … Regulatory Coordinator will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and ... regulatory ); MS degree or advanced certification in regulatory affairs or clinical research...Proficient with MS Word and Excel + Experience with FDA , EMA or other global health authority submissions is… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Hackensack Meridian Health (Neptune, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... + Bachelor's degree in Nursing + Minimum of 6 or more years of experience in clinical research experience. + Working knowledge of FDA and DHHS regulations, Good … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... and programs in accordance with company processes, SOPs, and FDA /ICH guidelines and regulations. The incumbent will lead the...phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both… more
- Sanofi Group (Bridgewater, NJ)
- …of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities. + Collaborate ... work in close partnership with other departments including brand teams and Public Affairs + Play a leadership role in developing, executing, and contributing to the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... + Excellent statistical knowledge and project planning skills + Knowledge of clinical trial research and regulatory requirements + Familiarity with SDTM/AdaM… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... medicine studies. + Collaborates with cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory , PK/ADME, Pharmacovigilance,… more
- Integra LifeSciences (Plainsboro, NJ)
- …which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs . + Generate technical ... technical investigation and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturer. + Effectively implement… more
