Skip to main content

Industrial Pharmacist - Regulatory Affairs Officer

Apply here

Ellen Claes
Recruiter



Ellen Claes
Recruiter
0499752248


Job description

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

Profile

  • 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


Apply now for Industrial Pharmacist - Regulatory Affairs Officer

Provide your contact information, education and experience so we can quickly see if you are a suitable candidate for the job.

Contact details

Education and experience

Number of years of experience*
0499752248