- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating,… 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
- 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
- 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
- Merck (Rahway, NJ)
- …such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of ... clinical research and clinical trial methodologies. + Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH guidelines. + Excellent… 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
- Pfizer (New York, NY)
- …Medical Outcomes organizations + Maintains strong working relationships with Global Medical Affairs Leads, Outcomes & Evidence, Clinical Sciences, PRD and ... mission is to inspire the medical community to enhance clinical practice and public health, driven by a deep...a thorough understanding of the processes associated with Medical Affairs . Working knowledge of lifecycle management and regulatory… more
- Pfizer (New York, NY)
- …care and (e) provide therapeutic area/product information for regional and other Medical Affairs and/or clinical development needs as necessary and approved by ... with Global Medical Affairs Leads, US Medical Affairs Brand Leads, Clinical Sciences, and Medical...Vaccines/AV, as needed **Operational Management:** + Anticipate evolution of FDA and other US regulations and guidance that impact… 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)
- …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)
- …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
- Pfizer (Parsippany, NJ)
- …Quality and compliance. + 5-7 years minimum experience focusing on Pharmacovigilance, Regulatory Affairs or within a Health Authority. + Extensive knowledge ... competitive positioning when solving problems and making decisions. + Clinical , Regulatory and Safety Expertise - Demonstrated...health authorities (including but not limited to the US FDA , EMA, MHRA) or with other global regulators is… 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)
- …**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