Description
Regulatory Affairs Specialist - CMC -Tunisia.A world leading international pharmaceutical organisation is seeking a Regulatory Affairs Specialist.
The Regulatory Affairs Specialist will join the organisations CMC (Chemistry Manufacturing & Control) department based in Tunisia.
The CMC department is responsible to carry out all activities that are needed to obtain new registrations and to maintain existing registrations for the projects and products of the organisations portfolio, in particular with respect to chemical/pharmaceutical aspects of the submissions.
Tasks:
Project work encompassing administrative and scientific regulatory activities varying from writing of technical summaries and filling of databases to compliance work
Draws up CMC documentation for international submissions
Takes part in the review and release of CMC documents in accordance with the applicable procedures
.Answers questions from health authorities and coordinates the Agency Response process
Makes proposals to the organization with regard to variations of chemical/pharmaceutical documents following questions from authorities. Consults with the departments involved
Has contacts with other staff of local companies and other sister companies
Is conversant with relevant, worldwide registration requirements (Preferred)
Requirements:
MSc (Biology, Pharmacy) or BSc with multiple years of experience
Minimum of 1 year registration experience in CMC (Preferred)
Good command of written and spoken English and French
Good editing skills
Has good social skills and is a good team player
Communicative person
A fantastic daily rate is on offer alongside a fantastic opportunity to join one of the worlds leading international pharmaceutical organisations.
Please apply today with a covering highlighting your key skills and relevant experience aligned to this contract opportunity.
Une organisation internationale de pharmaceutique cherche un specialiste des affaires reglementaires. Le specialiste des affaires reglementaires se joindra le departement de CMC (Fabrication et Contrôle de Chimie) dans l`organisation basee en Tunisie.
Le departement de CMC est responsible pour toutes les activities necessaires pour obtenir les nouvelles inscriptions et de maintenir les inscriptions existantes pour les projets et les produits du portefeuille de l`organisation, particulièrement aux aspects de soumissions chimique et pharmaceutique.