Job Reference: BBBH23114
Job Duration:
Start date: a.s.a.p
Description:
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 regulatoryresponses 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
Industry: Pharmaceuticals
Salary: €80000 - €120000 per annum
Salary Benefits:
Vacancy Type: Permanent
Job Skills: regulatory, director, head of regulatory, regulatory affairs director, Paris, regulatory
Contact Name: Tim Barratt
Website: -
Direct Application URL: -