Position: Regulatory Affairs Officer (m/f)
Are you a Regulatory Affairs Officer 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.
As a Regulatory Affairs Officer, your responsibilities will be:
- 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 inquiries 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
Regulatory Affairs Officer Experience Required:
- 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
The successful candidate will be on hand to provide operational input and support into the Regulatory Affairs function for Europe.
If you are interested in the role of a Regulatory Affairs Officer, please APPLY now!