Description
Regulatory Affairs Manager - 7 month contract - ZurichOur client, a leading pharmaceutical company based in Zurich is currently searching for Regulatory Affairs Manager to do the processing, maintenance care of old and new licenses for the marketability of drugs and medicinal products in Switzerland.
Tasks
- Marketing authorization applications for drugs and medicinal products (e.g. new marketing authorisations, line extensions, etc.)
- Maintenance of marketing authorisations (e.g. core data sheet updates, variations, renewals, PSURs, MR-conditions, etc.)
- Create and maintain the Local Product Document (LPD), Local Language document (LLD; Fachinformation), the local Patient Information Leaflet (PIL; Patienteninformation) and the abbreviated LLD (FI-kurz; Fachinformation kurz) as well as the packaging elements as appropriate in accordance with the local procedures and Swissmedic guidelines
- Secure the communication and archiving of the latest LLD/PIL and the FIkurz to all relevant stakeholders
- Be a competent and reliable contact for representatives of Swissmedic (actively maintain existing contacts and expand network at any emerging opportunity)
- Handling with all relevant global databases and systems and other applications, as appropriate
- Keep updated the local registration tracking of all new/ongoing applications, renewals and variations for the assigned products, and corresponding related databases/systems
Requirements
- A pharmaceutical or natural science degree.
- Extensive knowledge of the current Swiss regulatory and drug laws environment, knowledge about other legal environments (EU, US, etc.) is of advantage
- Solid knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine
- Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
- Ability to work independently as well as part of a team
- Ability to communicate effectively in German and English both verbally and in writing
- Relevant working/residency permit or Swiss/EU-Citizenship required
I am a specialized recruiter, currently taking care of various projects within the Regulatory Affairs field in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word including your hourly rate expectations for immediate consideration.
You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: Regulatory Affairs, German, English, Switzerland, marketing authorization, Swissmedic
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.