- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Associate **Date:** Nov 24, 2025 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** ... solutions that make a difference in patients' lives. **Position Summary** The Sr Regulatory Affairs (RA) Associate will be responsible for a variety of… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing ... in accordance with global regulations and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal ... Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological… more
- GRAIL (Carson City, NV)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Eisai, Inc (Philadelphia, PA)
- …vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads ... your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible...but not limited to Emerging MarketsAdvance experience with the drug development process and eCTD regulatory submission… more
- Merck & Co. (South San Francisco, CA)
- …Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) group is seeking an Associate Principal Scientist to contribute to our Company's biologics, drug ... conjugates, and novel modality discovery and development pipeline. The Associate Principal Scientist will be primarily discovery team-facing and is expected to be a… more
- Merck & Co. (Rahway, NJ)
- …degree is preferred.Leadership experience with working knowledge of device, biologic/ drug product, and process development including regulatory submission ... DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead ( Associate Director Equivalent) Our company's Device Product & Process Development… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical… more
- Insmed Incorporated (NJ)
- …of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approval Significant experience in global ... the future of science, we're in. Are you?About the Role:The Associate Director, Programming provides technical leadership and ensures adequate programming support… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director, Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational...and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that the manufacturing… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- Merck & Co. (Rahway, NJ)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Associate II as part of the Technical Operations team based in Raritan, ... NJ.Role OverviewThe CAR-T Warehouse Operations Associate will be part of the Technical Operations team...and efficient utilization of the warehouse space. Assist in regulatory inspections, perform safety and quality audits, and answer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has ... working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized...and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross… more
- Merck & Co. (Rahway, NJ)
- …robust operation while maintaining compliance with all current regulatory expectations.-Receives assignments, direction, and technical guidance from leadership ... policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory issues.- Provides technical, project management and system leadership.-Education… more
- Aequor (West Greenwich, RI)
- …bulk drug substance operations adhere to cGMP and other regulatory requirements. Key Responsibilities: Provide quality oversight for F&E, IQA Warehouse areas ... materials, processes, and products comply with cGMP standards and other applicable regulatory requirements. Review and approve work orders and job plans within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent ... certification program to ensure adequate qualification of auditors per regulatory expectations.Risk Management and Vendor Performance: Responsible to ensure the… more
- Organon & Co. (Jersey City, NJ)
- …authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Associate Director, Biopharmaceutics will ... **Job Description** **The Position** The Associate Director, Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of … more
- Parexel (Honolulu, HI)
- …for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at ... in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and… more
