Job Details:
My client was founded almost 30 years ago and is an internationally active consulting and service company with over 100 employees. They support clients worldwide in the development, approval and market access of medicinal products, food supplements and cosmetics as well as medical devices and invitro diagnostics. Now, they''re looking for a Regulatory Affairs Manager to join their growing team.
Regulatory Affairs Manager:
Your field of activity:
- Independent preparation of electronic dossiers (eCTDs/NeeS/eTD) with the help of appropriate software solutions
- Maintenance/use of authority portals and databases (e.g. xEVMPD, SPOR, pharmnetBund, CESSP, EMA gateway etc.) on behalf of customers
- Communication with national and international clients and regulatory authorities
- Control, preparation and updating of marketing authorisation documents for medicinal products in accordance with
European and international guidelines
- Independent procedural management and compliance with procedural timelines of national and
international regulatory procedures
- Cooperation with internal and external departments in the design and implementation of regulatory strategies and requirements
regulatory strategies and requirements
- Regulatory advice and support for our clients
Ideally, you should have the following skills and knowledge:
- Completed scientific education or comparable training
- Several years of professional experience (at least 5 years) in the field of regulatory affairs in the EU and ideally also outside the EU
- Relevant experience in the maintenance and use of regulatory portals and databases
(e.g. xEVMPD, SPOR, pharmnetBund, CESSP, EMA gateway etc.)
- Basic knowledge in the field of software validation
- Confident handling of MS-Office, Adobe Acrobat, docuBridge or comparable software for eCTD Creation of, as well as experience with RIMS (Regulatory Information Management Systems)
- Several years of experience with marketing authorisation procedures in Europe as well as in the preparation, coordination and submission of variations, renewals, and other marketing authorisation procedures,
submission of variations, renewals, with focus on centralised procedure (CP)
- Very good knowledge of German and English
If this sounds like a good match for your profile, apply now here or by sending me an e-mail, or get in touch via phone call for a confidential consultation:
Email: T.Chalkidou( @ )nonstop-recruitment.com
Phone: +49 892 109 3363
Internal Extension: 3514