Senior Manager of Regulatory Affairs

Employer
Proclinical Staffing
Location
Switzerland / Switzerland / Basel, Switzerland
Salary
Negotiable
Closing date
22 Sep 2020

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Contact Us
  • Eldon House
  • Eldon Street
  • EC2M 7LS
  • United Kingdom
  • 0800 988 4437
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