- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide ...if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process,… 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)
- …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
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... industry, consumer industry or health authority regulated industry + At least 3 years of Regulatory Affairs experience required with focus on the NA region and … more
- Sanofi Group (Bridgewater, NJ)
- …of US Regulatory strategies (eg, submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts). + Provide ... you will be the primary therapeutic area liaison with FDA 's Office of Prescription Drug Promotion (OPDP) for drugs,...started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising &… more
- J&J Family of Companies (Raritan, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... clinical team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations with regard to… more
- Bausch Health (Bridgewater, NJ)
- …Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical /Medical Affairs , Biostatistics, and Regulatory Affairs . + Lead the ... Responsible for the technical content and timely completion of clinical pharmacology deliverables as well as regulatory ...dermatology drugs is preferred. + Track record of successful regulatory agency (US FDA ) submissions and interactions… more
- Sanofi Group (Morristown, NJ)
- …clinical data. + Interact with relevant teams Innovation, Regulatory , Pharmacovigilance, Evidence generation (eg biostatisticians, Medical Writers, Monitoring ... team, eDS, etc.), Scientific Affairs and Growth (eg Marketing representatives when relevant). Common...Technical Document (CTD) + Coordinate the preparation of the clinical part of the CTD for FDA … more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …will also serve as the company pharmacovigilance expert, working in partnership with Medical Affairs and Clinical Affairs teams to bring important drug ... Vice President, Pharmacovigilance is responsible for providing business strategies that support FDA compliant Call Center and Safety data management systems in order… more
- Terumo Medical Corporation (Somerset, NJ)
- …NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more