- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the ... of the Head of Quality / Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- IQVIA (Parsippany, NJ)
- …regulatory document types; * May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications; * May be assigned ... Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is… 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)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Bristol Myers Squibb (Summit, NJ)
- …and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality Management Systems training elements **Qualifications ... + Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance… more
- J&J Family of Companies (Raritan, NJ)
- …of Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in ... Johnson & Johnson Innovative Medicine is recruiting for Associate Director, RA Submissions. The position can be... regulatory affairs , submission management, or a related… more
- Merck (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data ... range of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals. **Key… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director, Solutions and Industry Partnerships -Vaccines **Location:** Remote **About the Job** As the Associate Director, Solutions & ... designed for specific partnership channels + Work closely with HS Solutions, Public Affairs , HIT Solutions, Brand Marketing, and Market Access to ensure content both… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... design efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E - Work with the… more
- Sanofi Group (Morristown, NJ)
- …+ **Cross-Functional Collaboration** - Collaborate with internal stakeholders (R&D, regulatory , safety, medical affairs , commercial) to drive switch-related ... global medical strategies for Rx-to-OTC switch programs, collaborating with science, regulatory , and commercial teams to ensure alignment. + **External Expert… more
- Merck (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Hackensack Meridian Health (Edison, NJ)
- …compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries ... as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products. ... areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities… more
