...compliance. Oversee ongoing regulatory compliance of marketed products across their life cycle. 4. Regulatory Strategy & Business Partnership Advise senior stakeholders—including Commercial, Quality, ...
...Regulatory - Oncology - Single Sponsor Updated: October 2, 2025Location: Amsterdam, NH, NetherlandsJob ID: -OTHLOC-3528-2DR Description Senior Principal Medical Writer - Regulatory - Oncology - Single...
...regulatory affairs team, you will be responsible for the effective management and timely delivery of CMC regulatory documents, while maintaining compliance with global regulatory standards and commitm...
...&D), customers and suppliers. Manage and develop the Synres R&D Team. Manage Regulatory Affairs within Synres, in co-operation with Coim Regulatory Department. Employees : R&D Chemists, experts in syn...
...&D Director is part of the Management Team of Synres, and responsible for the Research and Development Department and Regulatory Affairs. The R&D Director reports to the Managing Director. Location : ...
...compliance. Oversee ongoing regulatory compliance of marketed products across their life cycle. 4. Regulatory Strategy & Business Partnership Advise senior stakeholders—including Commercial, Quality, ...
...Quality Strategy & Compliance Define and execute a quality strategy aligned with global standards (cGMP, FDA, EMA, WHO, SFDA). Ensure full compliance across all manufacturing sites, CMOs, and API supp...
...regulatory affairs (RA) manager will support regulatory submissions and compliance activities for clinical studies in the European Region and USA, with a focus on preparation of regulatory documents a...
...Regulatory Affairs & Pharmacovigilance Amsterdam, North Holland, Netherlands 1 month ago Senior Regulatory Counsel - Licensing & Affairs Amsterdam, North Holland, Netherlands 1 week ago Regulatory Aff...
...Regulatory Affairs (PSRA) manager Witcom product range of high-performance engineering plastics compounds to serve the automotive, industrial andE&E markets. Cawiton product range of hard and soft pla...
...Quality, Technical and Export managers). The regulatory officer is an expert in regulatory compliance with good communication and training skills. JOB DESCRPTION: Regulatory and Compliance Management ...
...quality systems, documentation practices, or regulatory environments (e.g., pharmaceutical, medical devices, biotech). Interest in developing expertise in audits, quality compliance, or regulatory aff...
...quality assurance in the Netherlands market. Familiarity with incident management, regulatory reporting, and maintaining evidence packs/audit trails. You combine strong Dutch regulatory knowledge with...
...& Licensing and work closely with the transaction leaders within the team as well as with key stakeholders across Genmab (R&D, Commercial, Technical Operations, Medical Affairs, Regulatory and Enablin...
...management tools in aspects across the quality management system, and product related elements to assess impact on product quality, and overall compliance with regulatory expectations and with the mar...