Beschreibung
Regulatory Affairs Specialist - Contract - Switzerland - 6 months+ - Immediate start
Are you a Regulatory Affairs Specialist with experience in the pharmaceutical sector? If so, Quanta may have the position for you.
Our pharmaceutical client based in Switzerland are currently looking for a Regulatory Affairs Officer to join their team on an initial 6-month contract.
The successful candidate will be on hand to provide operational input and support into the Regulatory Affairs function for Europe.
Responsibilities:
- Execution of regulatory submissions for obtaining (MAA) and maintaining (variations, renewals) approvals for the client's products in Europe in cooperation with the EU affiliates and the central RA support functions.
- Maintaining the relevant RA databases, archiving systems, etc.
- Contributing to regulatory strategies to cope with (future) licensing requirements
- Preparing and ensuring timely submission of answers to enquiries from regulatory authorities
- Maintaining and developing knowledge of specific regulatory requirements across countries in Europe
- Actively following the development/emergence of new regulatory requirements and assessing potential impact for existing products or product development
- Development of SOPs
- Developing and maintaining of product information and label.
- Previous experience of working in an International Regulatory Affairs role within the pharmaceutical industry.
- Good knowledge of European Regulatory Affairs
- Working knowledge of e-CTD, CESP.
- Awareness of XEVMPD
- Fluency in English, additional European language is a benefit
- Ability to communicate effectively with internal stakeholders at all levels and external parties as customers and business partners
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