- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate … more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director. Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development (SMAR&D) group has an exciting opportunity for an Associate Principal Scientist based in Rahway, NJ. Join us and experience our ... talented and dedicated colleagues while developing and expanding your career.-- As an Associate Principal Scientist, you will be part of a team develop ing… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the mission of ... ensuring the highest standards of scientific integrity, patient safety, regulatory compliance, and collaboration across therapeutic areas. Ultimately, this position… more
- Merck & Co. (Rahway, NJ)
- …products. Our team is looking for a candidate for the position of Associate Principal Scientist (R4) focused on developing parenteral drug products across a range ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Build deep fundamental knowledge around the drug… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The Role The Associate Director of US Medical Affairs Hematology Strategy will report to the Director, ... through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We have a hybrid model… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... change controls and maintain permanent inspection readiness and actively support regulatory inspections. This individual will also support the implementation of… more
- Merck & Co. (Rahway, NJ)
- …areas and routes of administration, including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of ... Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Warehouse Operations Associate as part of the Warehouse & Logistics team based in Raritan, NJ. Role OverviewThe Warehouse Operations ... Associate will be part of the Technical Operations Supply...and efficient utilization of the warehouse space. Assist in regulatory inspections, perform safety and quality audits, and answer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. SummaryReporting to the Senior Director, I&A, the Associate Director, Global Oncology Forecasting will drive creation of demand and ... revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global and regional… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director, GMP QA Process Excellence is accountable to collect information, ... the analysis and redesign of business processes. Ensure compliance with regulatory standards (eg, ICH, FDA, or other industry-specific requirements). Conduct regular… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Engineering Associate is responsible for assisting engineering activities related to the development, improvement, and optimization of the ... of new assetsCoordinate with Validation (VAL) to ensure compliance with regulatory requirementsCollaborate with Work Breakdown Structure (WBS) members on capex… more
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