EMEA Regulatory Affairs Senior Associate

Région
Braine-l'Alleud
Publication
lundi 19 juin 2017
Date limite
mercredi 19 juillet 2017
Réf
6E7E6XPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: EMEA Regulatory Affairs Senior Associate Organisation description:

XPE Pharma & Science is looking for 3 EMEA Regulatory Affairs Senior Associates, for one of our clients. The mission is of 6 months, with possibility of extension. This person will have to obtain and maintain marketing authorization for product(s) in Middle-East/ Africa region. A minimum of 4 years of experience are required; regulatory or equivalent experience within a pharma company CRO, or similar organization are preferred.

Job description:

Under limited supervision responsible for:  Obtain and maintain marketing authorizations for products in Middle-East/Africa region. Essential duties and responsibilities  Compile and submit in a timely manner regulatory documents according to regulatory requirements;  Respond to regulatory authorities with strict deadlines;  Maintain regulatory files in a format consistent with requirements;  Maintain and update existing regulatory authorizations;  Represent or lead Regulatory Affairs in small project teams.

Profile:

Education Bachelor's degree or country equivalent in pharmacy ore related scientific discipline. Higher degree/PhD would be an advantage. Experience A minimum of 4 years of experience Regulatory or equivalent experience within a pharmaceutical company CRO, or similar organization. Functional/Specific competences  Compile with regulations and standards and protect the company's public reputation;  Scientific knowledge;  Written and verbal communication skills;  Negotiation skills;  Technical systems skills (e.g. word processing, spreadsheets, databases, online research);  Manage multiple projects and deadlines;  Ability to contribute to multiple projects from a regulatory affairs perspective. Skills Excellent spoken and written English is required. Computer skills.

Offer:

Highly professional working environment; Open end contract on XPE payroll.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713