XEVMPD Submission Support

€25 - €32 per hour
  1. Permanent
Brussels
  1. Regulatory Affairs, Operations
Posted: 06/02/2020
BBBH13365

This vacancy has now expired. Please see similar roles below...

Hobson Prior are looking for a XEVMPD Submission Support to manage the submissions of medicinal product information to the EMA, following the PV legislation EU 1235/2010, Article 57 (XEVMPD). You will join a leading global biopharmaceutical company that has been inventing for life for more than a century.

Job Responsibilities:

  • Accountability's includes the Quality Control of submission-ready product information notified by the Regulatory Affairs department (Regional Center or EEA Countries).
  • The submission of product information data to the EMA (using Liquent InSight for Registrations).
  • The follow-up of EMA feedback.
  • The transversal monitoring of Data Quality.
  • The monitoring of compliance.
  • Support data consumers.

Requirements:

  • Bachelor's degree in scientific domain.
  • Language: fluent English, and knowledge of another EU language is highly desirable.
  • Experience: 2 years in pharmaceutical or regulatory affairs domain.
  • Experience in pharmaceutical/regulatory domains.
  • Experience with a pharmaceutical company RIM System.
  • Technical capabilities in managing large volumes of data.
  • Quality and analytics during execution.
  • Autonomy experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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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