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Job Details

Regulatory Affairs Director - Paris

Company: Key People Limited
Location: Paris
Reference: BBBH23114
Closing Date: 27 Apr 18
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

My client, a well-established Pharmaceutical company based in Paris, currently seeks an experienced Regulatory Affairs Director to join their growing team and lead a major clinical development program in oncology, inflammatory and neurodegenerative diseases. The studies are ongoing in phase 3 across 30 countries.

Requirements:

My client, a well-established Pharmaceutical company based in Paris, currently seeks an experienced Regulatory Affairs Director to join their growing team and lead a major clinical development program in oncology, inflammatory and neurodegenerative diseases. The studies are ongoing in phase 3 across 30 countries.

Responsibilities:
• Represent the company with the health authorities
• Supervise the constitution and follow-up of regulatory files
• Participate in the drafting of registration dossiers
• Participate in drafting regulatory responses to health authorities
• Ensure the management of the regulatory team
• Medical writing
• Provide advice and assistance on regulatory aspects to relevant departments

Profile:
• 10-15 years’ experience in regulatory affairs including 5 years in team and project management
• Significant experience in bidding and drafting regulatory responses to local health authorities in launching studies in a country
• Significant experience (in a pharmaceutical company) in drafting regulatory responses and clinical study documents (protocol, investigator brochure, clinical report)
• Post-graduate science degree (Pharm.D, or Ph.D.)
• Fluent English
• Strong analytical capacity, strong work capacity, adaptability in a fast-growing environment modalities

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

Apply for this job: Regulatory Affairs Director - Paris

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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