Regulatory Affairs Ops Specialist Senior

Negotiable
  1. Interim/Contract
Lessines, Belgium
  1. Regulatory Affairs, Operations
Posted: 06/06/2024
BBBH25537

Hobson Prior is seeking a Regulatory Affairs Operations Specialist for a contract role based in Lessines. The successful candidate will be part of the CQA and RA department and will be responsible for ensuring the product registration lifecycle and related processes in Europe This role requires a collaborative individual who enjoys working with internal and external stakeholders.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

  • Ensure timely preparation submission and follow-up of product variations and renewal applications.
  • Act as a point of contact with local authorities.
  • Respond to inquiries from regulatory authorities in coordination with the Global Regulatory Lead.
  • Manage high-quality labeling translation and artwork.
  • Review promotional materials for compliance with local regulations.
  • Maintain good relationships with internal and external regulatory contacts.
  • Monitor EU and local regulations perform impact analysis where needed and keep internal partners informed.
  • Provide regulatory guidance to business tenders and project teams.

Requirements

  • Bachelor's degree or equivalent in a relevant scientific field.
  • Previous work experience in regulatory or similar role within a pharmaceutical/medical device company CRO or similar organization.
  • Trilingual (Dutch French English).
  • Basic knowledge of Office applications.
  • Good interpersonal and communication skills.
  • Organizational and project management skills.
  • Self-motivated and committed.
  • Certification from Belgian FAMHP is a plus.
  • IT functional knowledge in Veeva Vault RIM & PromoMat TrackWise is an asset.
  • Proficiency in German is appreciated.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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