permanent
Regulatory Affairs Support Reference number: 1284
Last update: 22-01-2020, 09:45
Region: Brussels
Sector: Pharmaceutical
Education: Bachelor degree in scientific domain
Work experience: 2 years in pharmaceutical or regulatory affairs domain
Contract type: Replacement for a maternity leave
Job description
Our Client is looking for a Data The XEVMPD Submission Support activities that consist to manage the submissions of medicinal product information to the EMA, following the PV legislation EU 1235/2010, Article 57 (XEVMPD).

The Team is composed of 4-5 members working on XEVMPD-IDMP topics and will provide necessary on-boarding and support during the mission.
What you’ll do
  • This 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,
  • The support to data consumers…
Profile
  • Bachelor 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
Required Skills
  • 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
  • Knowledge of XEVMPD submissions to the EMA is a plus
  • Experience with Liquent InSight for Registrations is a plus
  • Experience with SharePoint and Excel
Interested? Send us your resumé
To apply for this job, please complete the form below and join your resume. This instantly places your information into our database. Once we have received your information, we will be in touch by e-mail or phone. If you have not heard from us after 3 working days, please call us!

Thank you for your interest in working with Harvey Nash and we look forward to assisting you in your job search!

Only PDF, max. 10MB

Only PDF, max. 10MB