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Amaris Consulting Logo Amaris Consulting · -

Regulatory Affairs Pharma

Belgium, Brussels · Job Posted May 28, 2026
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Job Description

The Regulatory Affairs Specialist is responsible for providing procedural, administrative, and planning support for new submissions and variation submissions in the EU, UK, Switzerland, and non‑EU Balkan countries for products approved through centralized and decentralized/MRP procedures. You will work closely with Country Regulatory Affairs teams and Regulatory Operations to ensure high‑quality, timely submissions in line with EU regulatory requirements.

Job Responsibility

  • Provide administrative regulatory support during the filing and review of new submissions and variations to ensure compliance with EU requirements
  • Plan and coordinate new submissions, variations, CHMP referrals, and FUM to ensure timely submission
  • Draft Module 1 components and coordinate the collection and organization of all Module 1 documentation
  • Collaborate closely with Regulatory Operations to define submission timelines and Module 1 content
  • Work in close partnership with Country RA Registration Managers to secure timely submissions in all relevant markets
  • For centralized procedures, supervise and coordinate the translation process to ensure on‑time submission to EMA
  • Provide additional administrative support related to Marketing Authorization Applications to senior Regulatory Affairs staff (Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist, Senior Scientist) as needed
  • Ensure accurate and timely updates to regulatory databases and tracking tools
  • Stay current with EU procedural requirements, guidelines, and legislation, and apply them in daily activities
  • Participate as Subject Matter Expert (SME) in relevant workstreams and projects as assigned by Regulatory Affairs Europe senior leadership

Requirements

  • University degree (or equivalent, e.g., A1 in Belgium), preferably in a scientific discipline related to medicine (e.g., Pharmacy, Life Sciences, Medicine, Biology, Chemistry)
  • 4–6 years of experience in the pharmaceutical industry, with solid knowledge of the drug development and/or approval process
  • Proven experience in EU regulatory submissions (centralized and/or decentralized/MRP) and lifecycle management is a strong asset
  • Good command of English (written and spoken)

What we offer

  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe
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