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Regulatory Affairs Manager

Introductie


At XPE Pharma & Science you're not just a consultant, you are one of a kind.


Not only will we track down the perfect assignment for you. Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. This by coaching sessions, development centers and performance reviews.


Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.



Organisatie- en afdelingsomschrijving


Our client is a research-based global company with its main focus on pharmaceuticals. For this project XPE Pharma & Science is hiring a multilingual (NL-FR-EN) Regulatory Affairs Manager with profound experience.


Functie-informatie


Purpose


As Regulatory Affair Manager you will be acting as a project manager for the lifecycle of both novel and established medicinal products for Belgium and Luxembourg. Compiling, submission and follow-up of registration files. Assure products are in accordance in accordance with pharmaceutical law.




Your responsibilities:


  • Manage registrations in Belgium and Luxembourg and update product information:
  • Prepare, submit and follow-up/coordinate registrations and variations via CP, DCP and MRP.
  • Evaluate, analyze and prepare variation dossiers that give rise to changes in module 3 (change controls).
  • Evaluate and analyze the product-specific documentation in response to the competent authorities’ evaluation and decisions of the EMA or the famhp, respond to remarks/questions and communicate internally.
  • Update, review and approve artwork
  • Maintain knowledge of legislation, guidelines and literature related to the job content
  • Answering (by phone and writing) of questions from doctors, pharmacists, patients,… with regard to the quality or action of the company’s products.
  • Communicate with the other departments on all relevant regulatory issues.


Ensure proper document management:


  • Keep database up-to-date
  • Filing and archiving of submissions in the corporate Document Management System.
  • Communicate changes to existing registrations.

Functie-eisen


Education:


Master pharmaceutical or biomedical sciences




Experience:


At least 5 years’ experience in Regulatory Affairs within the industry is a must.




Knowledge/ Skills:


e-CTD and NeeS

Excellent verbal and written communication skills

Languages: Dutch, English and French

Team player and team spirit

Detail oriented

Excellent planning skills

Stress resistant


Aanbod


You gain experience in a global pharmaceutical company and within a collaborative and entrepreneurial working environment where employees can be proud of the meaningful work they do!


 A competitive salary package that includes a car

 4 months’ mission

 Full time by preference, 80 or 90% is negotiable

 Flexibility


Inlichtingen bij


Not ready to apply or do you have questions first?

Please give me a call on +32 10 80 71 06, or mail: Kathleen.callebaut@xpe-group.net. I’ll be happy to give you more information!

Kathleen Callebaut

Recruitment  eXPErt


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