Regulatory Affairs Director

Key People


Job ID :

12710


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Paris,Paris,


Key Skills :

regulatory, director, head of regulatory, regulatory affairs director, Paris, regulatory


Salary :

€80000 - €120000 per annum


Date Posted :

27 Aug, 2018



Company Name :

Key People


Location1 :

Paris




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





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 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


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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