Job Description - Regulatory Affairs Support
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Regulatory Affairs Support

Ref: 57968

Posted today
Job Location
Wavre
Contract Type
Contracted at Modis

Introduction

At Modis we are looking for a RA support profile to work in Wavre. You are available immediately, have a first experience in RA and are fluent in English? This opportunity is for you !

Company/Department

Why would you work as a consultant for Modis Life Sciences?

  • Modis is a part of The Adecco group, one of the Top 5 companies within the 'Great Place to Work' ranking
  • Dynamic colleagues with passion and drive
  • The opportunity to develop yourself, your competences and skills within our organization
  • An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance, ...

Function information

Function description

  • Involved in the Company’s regulatory and administrative (including database entry) activities for this product line, in Europe and outside Europe (covering Emerging countries)
  • Ensure the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports etc …

Key responsibilities

- Job Holder (JH) to support the planning, coordination/preparation, submission and follow-up of MAAs and of life-cycle regulatory activities for the DTP vaccines in European Union and outside EU (covering Emerging countries):

  • Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
  • Ensure that all regulatory aspects on the product safety/pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled
  • Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
  • Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
  • Ensure each dossier/data-package submission is planned adequately: creation and update of record in RA Planning Database
  • Ensure each dossier/data-package is created in RA Document management database: with appropriate structure/folders/naming convention (in Computer Aided Regulatory Submission database: CARS), with “approval” of compiled dossier published
  • Ensure the tracking of relevant correspondence with Authorities and GSK Local Operating Companies (LOCs): in archiving database

- Communicate with relevant parties:

  • Communicate regulatory updated information to internal stakeholders

RA Planning Database :

Job Holder (JH) will provide support to the DTP team in entering submissions in database based on the appropriate information provided by the product responsible (product, countries, type of submission, timelines, resources …).

JH will also update the data in OPAL on an ongoing basis with input from product responsible (updating and closing events and tasks) and will permanently check the overdue activities and inform product responsible and “his/her” N+1 as necessary/appropriate.

Requirements

You have a scientific background, a first professional experience in Regulatory Affairs, are fluent in English and available ASAP?

You are flexible, team spirit, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment.

We are looking for you !

Offer

We offer you a good experience in a nice atmosphere with long term perspective; A long term full-time contract with a complete salary package (salary depending on experience + car + meal vouchers + insurances + ...)

Waiting for your CV and cover letter: sybille.ponet@modisbelgium.be / 028011665

Information

Please send cv and cover letter in WORD to apply. Thanks!

carine.steurs@xpepharmascience.com

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