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Director of Regulatory Affairs

Paris, France

 

Reference number : DRA1910

Genesis Pharma are currently recruiting for a Director of Regulatory Affairs, below is the JD for your reference...

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Director of Regulatory Affairs:
 
Job classification: Competitive Salary, Full-time, Permanent, 
 
Location: Paris


An exciting opportunity has arisen for a Director of Regulatory Affairs to join a Well Known Pharmaceutical Company renowned for its innovative therapeutic drugs, located in Paris. 
My client is looking for a Director of Regulatory Affairs with excellent experience in Regulatory Affairs and Medical Writing.


Main Responsibilities Will Include:
 

  • Being the company’s direct contact with the health authorities

  • Supervising the construction of regulatory files and follow-ups

  • Participating in the drafting of registration dossiers and regulatory responses to health authorities

  • Managing the regulatory team

  • Giving advice and assistance on regulatory throughout the company

 

A Bonus to have one or two of the following:

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  • Minimum 12-15 years’ experience in regulatory affairs

  • Experience in managing teams and projects

  • Significant experience in bidding and drafting regulatory responses to local health authorities in launching studies in a country

  • Significant experience within pharmaceuticals in drafting regulatory responses and clinical study documents such as; protocol, investigator brochure, and clinical report

  • Post-graduate science degree

  • Fluent English

  • Strong analytical capacity

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This is a full-time position with a competitive salary, perfect for a professional with experience in Regulatory Affairs and Medical Writing, who is looking to be part of new and exciting clinical developments.
                                                           

In order to apply for this role, please forward your most up to date CV and quote the reference number.

 

TAGS: Regulatory Affairs

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