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.
*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
*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 email@example.com