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Head of Regulatory Affairs, Paris

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
France
Region:
France All
Contract Type:
Permanent
Currency:
EUR
Salary:
100,000 to 120,000 per annum
Salary Description:
bonus and benefits
Posted:
08-Jan-20
Recruiter:
Key People
Job Ref:
24579

My client, a pharmaceutical company based in Paris, are currently recruiting for a Head of Regulatory Affairs to join their growing team on a permanent basis.

The client conducts a major clinical development program in oncology as well as inflammatory and neurodegenerative diseases, including 13 phase 3 studies underway in 30 countries.

The ideal candidate will have 12-15 years of Regulatory Affairs exposure.

Responsibilities:
*Representing the company to health authorities
*Supervise the constitution and follow-up of regulatory files
*Participate in the drafting of registration files
*Participate in drafting regulatory responses to health authorities
*Managing the regulatory team
*Provide advice and assistance on regulatory aspects to the relevant departments

Experience:
*Minimum 12-15 years of experience in regulatory affairs including 5 years in team and project management
*Significant experience in submission files and in drafting regulatory responses to local health authorities in launching studies in a country
*Significant experience(in pharmaceutical companies) in drafting regulatory responses and clinical study documents (protocol, investigative brochure, clinical report)
*Post-graduate science degree (Pharm.D, or Ph.D.)
*Essential running English
*Strong analytical capacity, strong working capacity, adaptability in a fast-growing environment

For further details about this role, or to discuss other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Closing Date:
06/02/2020

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