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Regulatory Operations Lead

Il y a 3 mois

Gent, Flandre, Belgique Argenx Temps plein

For the expansion of our Regulatory Affairs team, argenx is looking for a Regulatory Operations Lead, who will lead global regulatory operational activities and manages the operational aspects of eCTD filings and other regulatory filings to Health Authorities.


Key Accountabilities/Responsibilities:

The position will have the following key responsibilities:

  • Compiles content plans for original submissions and mayor post-approval variations
  • Coordinates with contracted publishing vendors for outsourced electronic submissions.
  • Works closely with Functional Area representative and/or Document Authors to compile documents needed for a submission, manage document upload and track documents for assigned projects.
  • Organizes and compiles regulatory submission documents e.g. perform of bookmarking using document publishing tools e.g. Adobe Acrobat pro and ISI Toolbox. Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance. Includes verification of bookmarks, hypertext links and tables of content in global submissions).

Desired Skills and Experience:

  • Detail oriented and well organized
  • Good oral and written English language skills
  • Active listening, understanding constraints from other disciplines
  • Critical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approaches to problems
  • Active learning: understanding the implications of new information for both current and future problemsolving and decisionmaking
  • Analytical skills: decision taking based on facts and figures rather than on assumptions
  • Experience with tools (e.g. Adobe Acrobat Pro) and systems (e.g. Electronic Document Management System)
  • Team player who seeks to help and learn from colleagues
  • High learning attitude and adaptability
  • At least Bachelor's Degree
  • At least3 years pharmaceutical or industry related experience

Offer:

  • A competitive salary package with benefits;
  • A work environment in a humansized, dynamic, rapidly growing biotech company