freelance
Regulatory Affairs Consultant Reference number: 1512
Last update: 14-09-2020, 17:28
Region: Brussels
Sector: Financial
Start: 14 Sep 2020    End: 13 Sep 2021
ASAP
Work experience: minimum 2 years
What you’ll do
  • 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.
  • Keep up to date with EU procedural requirements and legislation.
  • Liaising with Regional Submission Planner (accountable for planning in Regulatory Operations) to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines of Module 1 components.
  • Drafting and organizing the gathering of the module 1 components.
  • 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.
Profile
  • 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.
Required Skills
  • Needs to have knowledge about clinical research but this position is the step after clinical trial.
  • Evaluates activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation.
  • Considers the recent innovations when formulating recommendations.
  • to be able to liaise with agencies who do assessments, with the labeling group
  • to know the decentralize procedure to release products.
  • to assist the RA liaison in an rather administrative way to prepare Module 1 (application form per region - gather manufacturing info - check responsible persons - help with the production preparation form)to know where to look for guidance about required documents/annexes/GMP certificates
  • Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
  • to have experience in the European Legislation for new marketing authorizations and variations.
Interested? Send us your resumé
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