Beschreibung
Compliance Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 4 MM+
Main tasks:
- Support the reorganization from a compliance perspective (revision of local SOP, support the preparation of the Health Authority Inspection, organize training of Regulatory Affairs team and ensure readiness for the planned reorganization)
- Planning and project management of the reorganization
- Support the team in maintenance activities of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations
- Ensure timely preparation and maintenance of local Product Circular, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to company and local standards and Artwork Management procedures
- Ensure high quality translations and check of Product Circular and Patient Package Leaflets including linguistic and format check of these documents
- Implement Prescribing Information within the correct timeframes for compliance
- Ensure availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures; ensure the correct and proper utilization of artwork databases to generate mockup artwork and to implement revisions to artwork
- Ensure efficient and consistent implementation and use of internal and external regulatory databases and systems in Switzerland
- Ensure that files and archives related to Regulatory are kept updated and complete
- Participate in internal registration managers' meetings at regional level on selected issues
Main qualifications
- Master’s or Bachelor’s degree in Pharmaceutical Sciences or another relevant life science discipline
- Fluency in German, English and French is required.
- Previous experience in a registration department, regulatory agency or another related environment, include direct contact with regulatory agencies
- Strong attention to detail; proven ability to successfully handle conflicting priorities
- Strong organizational and project planning skills
- Experience in compliance activities like SOP writing, training activities
- Familiarity with Swiss and (if applicable) EU legislation procedures and guidelines governing pharmaceutical products; knowledge of the regulatory framework for vaccines is advantageous
- Ability to communicate well verbally and in writing is essential
- Demonstrated diplomacy and assertive skills in dealing with internal and external parties
Main advantages:
- Reputable international company
About us:
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.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
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