Head of Regulatory Affairs

My client, a small pharmaceutical company in the Paris area is looking for a Director of Regulatory Affairs on a permanent basis. The client specialises in the development of tyrosine kinase inhibitors in human and veterinary medicine.

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.

Missions
*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

profile
*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

If the above may be of interest and you feel you have a suitable profile, please apply and feel free to get in touch with Ross Wilson at rwilson@keypeople.co.uk for further details.