...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...
...& Group HR. Governmental and Regulatory Affairs: Manage relationships with regulatory bodies and contribute to industry regulation evolution. Ensure business compliance in a regulated sector of privat...
...Operations, Commercial, and Quality teams to ensure that compliance is embedded in daily operations. This role sits within our Legal & Compliance team and reports to the General Counsel. What you'll d...
...compliance standards and procedures across the region Provide training and guidance to teams in Supply Chain, Quality, Regulatory Affairs, Procurement and Engineering Drive projects focused on import/...
...&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 : M...
...Regulatory Affairs. Champion product quality, safety, and traceability in partnership with Quality and Supply Chain teams. Support production footprint decisions to ensure availability and cost‑effici...
...affairs, regulatory affairs, and sales and marketing teams, to ensure awareness and compliance with safety requirements. Participates in strategic initiatives to enhance the overall safety profile of ...
...regulatory reporting systems and maintain proper record-keepingYour Profile3–5 years’ experience in medical device regulatory, quality, or product-related roles, or a relevant degree in Regulatory Aff...
...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...
...& 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...
...Regulatory (RA/QA) Specialist, you take ownership of the regulatory and quality landscape within Luscii. In this role, you ensure that all applicable regulatory and quality requirements are in scope, ...
...compliance teams. Budget Adherence - Maintain or exceed financial targets with disciplined cost management. Quality & Compliance - Ensure full adherence to regulatory and animal welfare requirements. ...