- Takeda Pharmaceutical (Boston, MA)
- …objectives for complex and/or multiple projects. Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory ... bring life-changing therapies to patients worldwide.The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
- Merck & Co. (Rahway, NJ)
- …Knowledge:In-depth understanding of Autoinjector design, manufacturing processes, and regulatory requirements.Familiarity with materials science , particularly as ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional ... regulatory strategy, objectives, policies, and programs pertaining to developing...BSc, MS, MSc, PhD, PharmD, JD, or MD in science or healthcare preferred or equivalent relevant experience. Has… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... patients, for each other, and for the future of science , we're in. Are you?About the Role:The Associate Director,..., we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the… more
- Legend Biotech USA, Inc. (Detroit, MI)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Medical Science Liaison as part of the Medical Affairs team based in Great Lakes ... & IL). Role OverviewAs part of the US Medical Affairs team, the Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs)… more
- Insmed Incorporated (San Diego, CA)
- …the future of science , we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... patients, for each other, and for the future of science , we're in. Are you?About the Role:This position is...Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve… more
- Merck & Co. (Rahway, NJ)
- …Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Physiology, Regulatory Compliance, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Tris Pharma (Monmouth Junction, NJ)
- …products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, ... will apply model-informed drug development (MIDD) principles to support translational science and clinical development plans from first-in-human through late phase… more
- Merck & Co. (Durham, NC)
- …The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to EHS as ... of required reports to site, divisional and/or corporate management and regulatory agencies.Manage budgetary & capital needs to support EHS initiatives, projects… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Merck & Co. (Rahway, NJ)
- …and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires ... and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and… more
- Merck & Co. (Rahway, NJ)
- …development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership ... the assembly and packaging platform portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Merck & Co. (Rahway, NJ)
- …development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership ... MDCP assembly and packaging platform portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Merck & Co. (Rahway, NJ)
- …team of environmental, health and safety professionals, providing technical and regulatory support and implementation of all necessary measures and initiatives ... action.Lead site and/or local area audits for compliance with applicable regulatory requirements (ie OSHA, EPA, DEP, etc.). Translate Corporate and Divisional… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical leader with ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... list in the UK.For patients, for each other, and for the future of science , we're in. Are you?About the Role:The Associate Director, Quality Control will be… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... Work list in the UK.For patients, for each other, and for the future of science , we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for… 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
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
