- Merck & Co. (North Wales, PA)
- …processes (SOPs) and software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process development ... In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position… more
- Genmab (Plainsboro, NJ)
- …issues to CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Merck & Co. (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... independently with minimal supervision and/or lead QP2 efforts on drug /vaccine development programs, and author or co-author strategic documents.Associate Directors… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the drug development process with thorough ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, ... around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Regulatory Affairs Intern for summer 2025. This full-time position works for approximately ... 37.5 hours per week. Responsibilities:Support Regulatory Affairs Chemistry, Manufacturing, and Controls team with Investigational New Drug Application and… more
- Aequor (Chattanooga, TN)
- …Procedures (SOP's), Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration (FDA) regulatory standards. Maintain compliance with all ... state and federal regulations. Support reduction in environmental impacts across all sites, including energy savings and utility monitoring. Establish and maintain constant communication across all levels of the organization. Qualifications Education/Training… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …track record in executing effective project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical ... industry.Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality, and risk management… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply (GCDS) ... operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the ability to exercise… more
- Genmab (Plainsboro, NJ)
- … supply plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, ... best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS)… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... - The GPAM Associate Director, Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering with team leaders to… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Merck & Co. (Rahway, NJ)
- …product portfolio.-3. Collaborate with cross-functional partners, including R&D, Quality, Regulatory , Manufacturing, Technical Product Leaders, and Value Chain to ... and improve product stewardship practices, while ensuring compliance with regulatory requirements.6. Foster a culture of excellence, mentorship, and professional… more
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