Senior GPRM/RegCMC Associate Director
Posted on Feb 9, 2021 by RM IT Professional Resources AG
Senior GPRM/RegCMC Associate Director vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Strong knowledge of regulatory development, submission and approval processes in at least one major regions for drugs and medical devices, including digital devices
- Experienced in leading teams in health authority negotiations and regulatory submissions and in driving good regulatory practice for in-market pharmaceuticals
- Awareness of the variety of regulatory diversity around the globe for promotion and marketing of launched medicinal products and associated medical devices
- Strong communication, collaboration, writing and problem solving skills paired with an independent work manner
- University degree as a BSc or MSc, advanced degree is preferred
- Languages: English, fluent in written and spoken
- Working as part of the RA Innovation group and ensuring compliance with global regulatory requirements and adherence to regulatory internal policies and processes
- Providing regulatory leadership on digital tools development supporting global and local commercial and development teams
- Acting as global regulatory contact with local teams and connects with other internal experts to provide coordinated, cross-functional guidance and support to business units and partner companies
- Supporting key regulatory submissions including CTAs, INDs, 510Ks, PMA, IDEs, NDAs, drug dossiers and device clearance planning processes
- Providing input into the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) for digital-technology supported drugs
- Developing high quality regulatory strategy for selected global projects
- Acting as the Novartis regulatory contact and supports HA interactions, including the preparation and finalization of briefing books
Location: Basel, Switzerland
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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