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Regulatory Affairs consultant - health animal

1 hour, 52 minutes ago
Belgium
Contract
Senior
Consultant
Operations
Apply Now
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014
View All Jobs 6

Description

  • Manage all activities related to the obtaining, follow-up, and maintenance of Marketing Authorizations in France and Europe.
  • Submit and track Marketing Authorization applications at national and European levels.
  • Prepare, submit, and follow up on regulatory evaluations with Competent Authorities.
  • Handle pharmaceutical variations, MA renewals, Requests for Amendments to Product Information (DMI), and regulatory variations through implementation.
  • Monitor product registration in the Generic Groups Directory.
  • Act as an interface with internal departments, external experts, API manufacturers, and contract manufacturing organizations (CMOs).
  • Report to the Registration Department Team Manager on regulatory activities and progress.

Requirements

  • Qualified Pharmacist or Master’s degree.
  • Solid experience in Regulatory Affairs in Veterinary Medicine.
  • Excellent interpersonal skills and strong writing skills in both French and English.
  • Operational level of English with good reading comprehension and written communication abilities.
  • Well-organized and detail-oriented.
  • Self-motivated and autonomous with the ability to manage priorities effectively.
  • Strong analytical and synthesis skills.

Benefits

  • Join a young, ambitious health company with 900 Excelyates.
  • Work toward becoming part of Europe’s leading mid-size CRO.
  • Access a one-stop provider model offering full-service, functional service provider, and consulting projects.
  • Opportunity to work alongside preeminent experts.
  • A stimulating environment that supports personal and intellectual growth.
  • An inclusive culture that values collaboration, audacity, care, and individual growth.

Interested in this position?

Apply directly on the company website

Apply Now

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