- 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
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review… 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
- Veterans Affairs, Veterans Health Administration (New York, NY)
- …to persuade and influence clinical and management decisions. b. Expert understanding of regulatory and quality standards for their program area. c. Ability to ... integrated with other services' function. The incumbent performs process improvement, quality assurance and administrative functions as requested that are inclusive… more
- VNS Health (Manhattan, NY)
- …as necessary and appropriate. + Collaborates with cross-functional teams, including Operations, Quality , IT, Compliance, Government Affairs , and Risk, to ensure ... compliance and identify risk areas. Serves as the primary liaison to outside regulatory counsel. Works within the Chief Legal and Risk Officer Organization ("CLRO")… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director, Quality Management System will be responsible for supporting ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… 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
- J&J Family of Companies (Raritan, NJ)
- …of Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in ... Johnson & Johnson Innovative Medicine is recruiting for Associate Director, RA Submissions. The position can be... regulatory affairs , submission management, or a related… 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
- Merck (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data ... range of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals. **Key… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... design efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E - Work with the… 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 (Bridgewater, NJ)
- **Job title** : Associate Director, Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... of patients around the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty Care Communications team to support… 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, Statistical Programming is responsible for building and maintaining a… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Consumer Marketing - US Rare Hematology **Location** : Cambridge, MA **_About the Job_** This role will drive consumer marketing ... include, HCP marketing, Global Marketing, Sales, Research & Development, Medical Affairs , Business Development, Market Research, Life Cycle Management and Finance… 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
- J&J Family of Companies (Raritan, NJ)
- …This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior Local Trial ... is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical… 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