Regulatory Affairs Manager job in Paris, France

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First Name*

Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Project Manager

Location: France

This vacancy has now expired. Please see similar roles below...

A popular biotechnological company are looking for Regulatory Affairs Manager to join their team working remotely from their location. This is a unique opportunity to join a company that can transform the face of medicine.

Job Responsibilities

Regulatory compliance
Scientific support for the preparation of regulatory dossiers
Participate in the selection and justification of Registered Starting Materials (RSM) and their characterization.
Evaluation of technical information on processes developed/optimized by R&D or "Technical packages".
Identification of associated quality and regulatory risks
Management of risk analyses of elemental impurities and nitrosamines
Writing scientific reports and documents related to your field of expertise
Elaboration of the strategy for the control of active substances

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
Skills in organic chemistry
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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