Regulatory Affairs Specialist

Vue: 115

Jour de mise à jour: 26-11-2025

Localisation: Wavre Walloon Brabant

Catégorie: IT - Logiciel IT - Matériel / Réseaux Informatique Marketing / RP Ventes

Industrie:

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le contenu du travail

Interested ? Don’t hesitate to take a look at the job description below !

megane.libert@professionals.randstad.be

Industrial pharmacist or master in sciences with minimum 5 years experience in RA fields in the API manufacturing sector
Fluency in French and English is mandatory (spoken and written English)
Excellent command of Word, Excel and Power Point
High organisational skills, good interpersonal skills, flexibility in tasks and schedules
Sense of responsibility, enthusiasm, diplomacy and team spirit

Consulting in view of a permanent contract

We offer an attractive salary with extra-legal advantages:

A rate as freelance is also possible

Our client is an internationally recognised biotech group based in Braine-l’Alleud.

Work within the Quality and Regulatory team to maintain focused, effective progression in line with objectives
Inform management in case of any major quality or regulatory issue
Compile registration applications. The regulatory department is working closely with the involved departments with the customer
Regulatory ensures the high quality of the regulatory submission documentation and that it contains the appropriate information required by the authorities
Ensure timely submissions to health authorities
Ensure that registration applications are approved by the relevant authorities
Maintain registrations in compliance with the procedures in place and with the current regulatory regulations
Provide regulatory guidance as needed
Have knowledge in applicable regulatory guidelines
Assist sales and marketing in promoting and giving potential and current customers the highest possible quality service
Be the direct contact with customer’s and regulatory authorities regarding clinical trial and marketing applications / authorisations
Work with global RA projects and with support to RA at other sites as assigned

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