Support RA activities 2058

16-9-2019 bruxelles
company profile

Their mission: To discover, develop and provide innovative products and services that save and improve lives around the world.

job description

Do you have at least 2 years experience in the pharmaceutical industry and knowledge of EU regulatory procedures?

Don't hesitate to contact me:

Support RA activities in the EU region, the non-EU CES countries + Switzerland-close collaboration with the RA Liaison Primary activities include, but are not limited to: 

  • Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements
  • Liaising with Regional Submission Planner to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines
  • Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies
  • Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling
  • For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA
  • Ensuring updates to regulatory databases 
  • Keep up to date with EU procedural requirements and legislation

your contribution

  • Degree in life sciences
  • Minimum of 2 years experience in the pharmaceutical industry
  • Knowledge of EU regulatory procedures and development of medicinal products in general is preferred
  • Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English
  • Demonstrates the ability to review regulatory documents for accuracy
  • Understands the end-to-end pharmaceutical lifecycle

what do we offer?

We offer an attractive salary with extra-legal advantages : 

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car 
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible

project manager (m/f)
employment type
full time, freelance
contract type
long term contracts
your Randstad contact
Aurélia Sautière 02 474 60 16
02 474 60 16