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Regulatory Affairs DirectorRef: BBBH23114

Salary:€80000 - €120000 per annum

Added:14 Sep 2018

Region: France

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

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

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