- Merck & Co. (Millsboro, DE)
- …are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in the US however ... Driving License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Audits Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs , Employee Training Programs, Global Communications,… more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) by:Developing an active engagement… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry. Education area of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Leica Biosystems (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work… more
- Cepheid (Miami, FL)
- …to the world.Learn about the Danaher Business System which makes everything possible.The Regulatory Affairs Principal is responsible for serving as RA lead on ... instrument, software projects and/or system projects.This position reports to the Director Regulatory Affairs , NPD and is part of the Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations).Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Merck & Co. (South San Francisco, CA)
- …as immunology, neurology, cardiometabolic and others as needed by the pipeline.Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ... between thought leaders and internal stakeholders, encompassing R&D, medical affairs , marketing, and market access teams, to drive innovation, scientific… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... required documentations and change control activities, in liaison with PD/QA/QC/ Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs , Integrated Customer Engagement, Global and other relevant NNI ... device and digital market and solutions, including technological trends, regulatory landscape, and competitive dynamics Strong knowledge of the pharmaceutical… more
