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Last Name*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: Switzerland

Proclinical have partnered with a global pharmaceutical company to find a talented Senior Regulatory Consultant who is an expert in vaccine products. This Zurich based role is initially for 12 months with the opportunity to extend.

Job Responsibilities

Oversight of Regulatory activities (including registration, lifecycle & development)
Support submissions for vaccine products across Europe (dossier / MAA)
Operation support across all aspects of drug development and approval
Oversight of clinical trials in Europe
Collaboration with other regions on strategy for projects
Participate in the selection and justification of Registered Starting Materials (RSM) and their characterization.
Identification of associated quality and regulatory risks
Management of risk analyses of elemental impurities and nitrosamines

Skills and Requirements

Good knowledge of regulatory procedures (EU/ France)
Knowledge in CMC
Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
Experience in CMC writing (Variation package) will be appreciated
Knowledge of the usual analytical methods (LC-UV, LC- MS, GC-FID, etc...) and ICH standards.
Fluent in English and French and another European language for daily contacts with local and international partners

To Apply

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-KM2

#RegulatoryAffairs

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