Referenznummer: 417237/1 Startdatum: asap Projektdauer: 12 MM+ Ort: Basel region
Provide expert knowledge on regulatory requirements and environment for assigned International countries
Be a strong partner to affiliates and the global product teams, finding innovative solutions and challenging the status quo
Liaise with global teams to ensure clinical development requirements in International countries are integrated into the global development plans
Accountable for clinical trial application strategy and support to Clinical Trial Regulatory Management group for dossier dispatch
Collaborate with global and local stakeholders (e.g. affiliate DRAs, Labelling Managers and International Technical Partner) to generate and deliver the product strategy, ensuring timely submission of regulatory applications (initial licenses, new indications and lifecycle management)
Advocate and champion DRA affiliates within the global organisation, ensuring that the affiliate voice is represented within headquarters
Lead planning of health authority meetings and lead response to health authority questions and provide authoring support as needed
University Degree, preferably in a scientific discipline
Experience with International Drug Regulatory Affairs
Knowledge and experience of global regulatory processes
Good practical experience of contacts with health authorities
Basic working knowledge of core processes in discovery, development, manufacturing and marketing
Fluency in written and spoken English
A very renowned company
Über Hays: With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Einsatzort: Basel region
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