- 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
- 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
- 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
- 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
- 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
- The Fountain Group (Cambridge, MA)
- …Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is ... working in Pharma with at least 3 years of Regulatory CMC experience (manufacturing and testing). Experience delivering CMC...experience is a plus. This role is responsible for Regulatory CMC expertise into the development and implementation of… 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 ... 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
- 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
- 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. (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
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager… 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
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and ... assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions. Requirements:… more
- Accede Solutions, Inc. (Lexington, MA)
- Hybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This ... to the corporate goals. Coordinate responses to CMC-related inquiries from regulatory agencies with thorough submission management Support preparation for Health… more
- Omni Inclusive (Trenton, NJ)
- …a strong background on critical and diverse topics related to the pharmaceutical industry (issues, trends) and be able to effectively identify opportunities and ... organizing tasks, with ability to appropriately prioritize and act proactively *Prior pharmaceutical experience a plus, but not required. Subject matter expertise in… more
- Glass Family of Companies (Whippany, NJ)
- …for external and internal use. Collaborate with cross-functional teams including Medical Affairs , Regulatory , and Legal to review and help ensure scientific ... Opportunity Details Full Time Senior Manager, Medical Affairs Communications - Oncology Senior Manager, Medical ...information. Skills Required 1-2 years of experience in the pharmaceutical or medical device industry. Prior experience in a… more
- MMS Holdings Inc. (Canton, MI)
- …related experience, Masters or PhD preferred. Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience ... culture and industry best employee retention rate. We support the pharmaceutical , biotech, and medical device industries with our proven, scientific approach… more
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- …supervision. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Participate in global regulatory ... Scientific Discipline (master's or higher preferred) with. 3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience.… more
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