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Industrial Pharmacist - Regulatory Affairs Officer

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Ellen Claes
Recruiter



Ellen Claes
Recruiter
0499752248


Description de l'emploi

Regulatory part

As Regulatory Affairs Officer, you are in charge of the different missions related to the regulatory affairs for both entities in Benelux by being supported by the corporate regulatory team.

Your responsibilities would include:

  • Submission of the variations to our existing Marketing Authorizations
  • Update of the SPC, leaflet, labels of each medicine
  • Managing communication with Benelux authorities in relation to these topics

You work under the supervision of the Responsible for Information and Publicity (RIP), where you will be in charge of registration and verification of sponsoring and communication requests. Yearly you will report these transfers of value on the national ethical platforms in order to publish these transfers to the public.

Vigilance Part

As Deputy LPO you manage the reception, registration and follow-up of the pharmacovigilance and materiovigilance cases.

GMP/GDP Part

  • You guarantee compliance with GDP
  • By performing monthly auto-inspections, you check authorized activities of reception, storage, transport and distribution of medicines and medical devices on these sites.
  • You manage non-conformities on site and implement corrective actions. You are fully involved in GDP inspection from belgian authorities. 
  • You are back-up for the release of medicines on the different GMP sites

Profil

  • Industrial Pharmacist degree (Belgian QP number - or the possibility to request one)
  • 1-2 years experience in regulatory affairs
  • Languages : Dutch, French, English
  • Strong organization and communication skills


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Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
0499752248