Regulatory Affairs Consultant M/w/x - Sint-Lambrechts-Woluwe, België - SMART BUSINESS CONSULTING

Beschrijving

**Description de l'entreprise
**Smart Business Consulting is consultancy firm in the life sciences industry that grows by helping the world's leading companies meet their challenges of transformation and innovation.

Our mission is to deliver high quality client service by consistently delivering value with the highest performing teams.

We support our customers from concept to industrialization to achieve their goals and deliver to them the service that fits their needs.

We are hiring Regulatory Affairs Specialists for our clients in Belgium.


Description de la fonction

• Management of Variation registration
• Provide regulatory impact assessment for different changes.
• Authoring regulatory life cycle variations/supplement
• Authoring CMC part of regulatory file
• Authoring summaries of different source document

Description du profil

• Master/PhD in Scientific area
• Minimum of 3 years experience in Regulatory Affairs environment
• Good knowledge of guidance and regulatory requirements
• Understanding of drug manufacturing process and quality systems
• Strong interpersonal and communication skills
• Fluency in French and English

Permis de conduire
Permis B


Informations supplementaires
Lieu de travail Woluwe-Saint-Lambert, Belgique


Type de contrat :
Travail