- 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
- Merck (Rahway, NJ)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- Stryker (Mahwah, NJ)
- …We are currently seeking a **Senior Regulatory Affairs Specialist** to join ... regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory...for responsible products/technical files + Author and submit electronic regulatory submissions for the FDA and Notified… more
- 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
- Veterans Affairs, Veterans Health Administration (Bronx, NY)
- …regarding complex clinical and technical issues. 3. Skill in utilizing regulatory and quality standards to develop and implement operational programs. 4. Skill ... Medical Center is currently recruiting for Associate Chief of Pharmacy of Clinical Operations will be responsible for the supervision, coordination and development… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all ... aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that ... aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary:** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate ... trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related...and drug coding conventions (MedDRA, WHO-DD) - Knowledge of FDA and global PV regulations, clinical and… more
- Sanofi Group (Morristown, 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
- 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
- Sanofi Group (Morristown, NJ)
- …**About you** **Experience** : + 1+ year of experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs or Quality Assurance. + Experience in ... grow. We provide those opportunities in various functions such as: marketing, finance, regulatory , supply chain, clinical trials, production, etc. and in more… 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