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This is a superb contract opportunity for an experienced Regulatory Affairs Professional with excellent and fully negotiable rates of pay.
Accountabilities/Responsibilities
-Ensure awareness of new requirements and European regulatory intelligence and inform colleagues as appropriate
-Provide service for European and non-European regulatory processes for pharmaceutical products
-Contribute to the development of core procedures (local and global) to ensure high quality documentation and submissions
-Provide EU regulatory expertise to assigned product development teams
-Input of regulatory strategy for product development, MAAs und life cycle management
- Clarification of specific content-related questions for product development (CMC, nonclinical, clinical)
- Coordinate process of review of various documents (e.g.: study protocols, clinical study reports, Informed Consent Forms, expert reports, CMC documents, MAA and CTA application forms
- Coordinate process of preparation, release and maintenance of CTAs in EU, European and other countries.
-Preparation and release of Marketing Authorization submission dossier (new applications and line extensions)
-Provide EU regulatory services to the maintenance of assigned marketed products:
-Preparation and release of the following submission dossiers:
- Variations
- Renewals
- PSUR submissions
Essential Skills & Capabilities:
-University degree in medicine, pharmacy or life science
-About 3-5 years experience in Regulatory Affairs
-Experience in European procedures
-Experience in global product development
-Ability to work collaboratively in complex team environment
-Computer literate
-Fluent in English, written and oral
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