Technical Regulatory Writer

Région
Wavre
Publication
mardi 2 octobre 2018
Date limite
vendredi 2 novembre 2018
Réf
83AF2XPE-BE
Contact
Kathleen Callebaut
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Technical Regulatory Writer Organisation description:

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.

Job description:

The Technical Regulatory Writer is involved in the company's regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions. Write CMC, “facility and equipment” parts and new files for WW regulatory File. Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion. Ensure the coordination with the departments involved in the writing/review process Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities Monitor that supportive data provided by other departments are compliant. Report significant issues Manage the projects within all GSK/GRA tracking tools Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.

Profile:

Knowledge/skills: University level (Life Sciences background is preferred) or equivalent by experience. Knowledge of regulatory procedures / systems / guidances Good level of spoken and written English and French Knowledge of biologic process and process equipment. Knowledge of Qualification / Validation principles. Soft skills: Manages own time to meet agreed short-term targets Good communication and writing skills Ensures the coherence between contributions / quality of final results Team player Experience: Experience in writing CMC (technical) parts of regulatory documents (registration files or variations). Experience working in validation/QA/production in Biologics/Pharmaceuticals industry

Offer:

Working as a consultant for XPE Pharma & Science means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713

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