Regulatory Affairs Assistant
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#NL30414 Type: Full time
Job Description
- Compilation of technical dossiers (Modules 1, 2.3, 3) for new development pharmaceutical products
- Update existing technical dossiers of pharmaceutical products, in order to comply with current EU requirements or other country specific requirements (for non-EU registrations)
- Preparation and submission of registration files to the competent authorities for new product applications, variations, notifications, renewals
- Handling correspondence with the competent authorities
- Filling-in & keeping up-to-date company databases with registration information
Candidate’s profile
- University degree (preferably in Pharmacy, Chemistry or Biology)
- 2-3 years of experience in a similar position will be considered an asset (CMC, registration procedures)
- Excellent command of the English language
- Computer literacy
The company offers
- Continuous training and opportunities for professional growth
- Friendly and challenging working environment
- Competitive benefits package
All candidates will be treated in strict confidentiality