Regulatory Affairs Associate - CMC

Région
Flemish Brabant
Publication
vendredi 1 juin 2018
Date limite
dimanche 1 juillet 2018
Réf
8011AXPE-BE
Contact
Astrid Kinoo
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDD
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Associate - CMC Organisation description:

Our client is a pharmaceutical company in generic medicines, they are hiring a trilingual (NL-FR-EN) Regulatory Affairs Associate with profound CMC experience.

Job description:

The Regulatory Affairs Associate has the operational responsibility for registration of dossiers and maintenance of registrations in Belgium.

He/she has a key role to insure products could be marketed in accordance with regulatory requirements and guidelines.


Registration and submission dossiers

The optimal preparation, submission and follow-up of registrations (NP, MRP, DCP) is one of your most important responsibilities. Always be pro-active and inform about issues, in this case, actively propose solutions and ensure maintenance of registration dossiers (variations, renewals, PSURS).

You will have close interaction and collaboration with other departments of the local (QA/PV/Medical Affairs) and European Central RA Organization to collect information necessary for submissions.

Furthermore, you give administrative support for pricing and reimbursement procedures.


Management of regulatory projects

Your participation in the management of regulatory projects and their implementation is required.


Procedures & Compliance

You create RA procedures and work according to those procedures/guidelines within the department.

Finally, you assure a good collaboration between the RA and QA and PV department in order to assure the compliance of marketed products with the current approved registration file.

Profile:

The ideal candidate has a master in health sciences and proven experience.


At least 2 years' experience in Regulatory Affairs and CMC within the pharmaceutical industry is a must.


English, Dutch and French hold no secrets from you and you can effectively and fluently communicate both in writing and orally.


You know how to handle NeeS and eCTD and CESP sublmissions.


And finally, if the words: innovative, reliable, team player and accurate; cover your personality, you are the RA professional I am looking for!

Offer:

You are offered a permanent, full time contract directly on our client's 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

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