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Head of Regulatory Affairs, ParisRef: 24579

Salary:€100000 - €120000 per annum + bonus and benefits

Added:13 Feb 2020

Region: France

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

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

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