Beschreibung
Senior GPRM/RegCMC Associate Director vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- 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
Your tasks:
- 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
Start:
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH16589
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.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:
- All administrative questions
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- Work permit and much more
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