- Merck & Co. (Rahway, NJ)
- …Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- …Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs ... CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline...to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …redesign and SOP authoring/coordination (Required)3 or more years with focus on pharmaceutical regulatory affairs , incl. familiarity with regulatory ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics… 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 ... industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical ...CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and 4+ years direct or related… 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
- Eisai, Inc (Nutley, NJ)
- …with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to ensure compliance with Eisai policies & standard operating ... Strong knowledge of emerging trends in digital innovation and technologies in medical affairs and the pharmaceutical industry. Strong overall written and verbal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (WA)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Olema Oncology (Boston, MA)
- …clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical ... As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of labeling for… more
- Eisai, Inc (Nutley, NJ)
- …with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to ensure compliance with Eisai policies & procedures.Provide support ... knowledge of emerging trends in digital innovation and technologies in medical affairs and the pharmaceutical industry.Strong overall written and verbal… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …minimum 5+ years or Master's/ Bachelor's with minimum 8+ years relevant experience in pharmaceutical regulatory affairs . Minimum of 5 years of experience ... Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this… more
- Cedent (Boston, MA)
- …We're Looking For *Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement in ... As a Clinical Trial Regulatory Affairs Specialist, you will be responsible for: * Regulatory Compliance: Ensuring all clinical trials adhere to applicable… 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
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10...given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10...given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part of the… 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 ... a steady career progression with increasing roles of responsibility within the pharmaceutical industry At least two (2) years of people leadership experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
