BrightOwl Loader Loading

Junior Regulatory Affairs - Spain  

Lilly (company)


Posted on : 13 May 2017

Project Description

Main responsibilities:
  • Requesting / Archiving/ Provision of Official Certificates.Samples required to support submissions.
  • Dossier compilation from the Regulatory Tracking Tool.Shipment and archiving of original documents
  • Provide administrative regulatory support for Chemistry 
  • Manufacturing Control registration submissions of products / contract manufacturers.
  • Consult Regulatory Database for information of the requirements of the countries to assure an adequate support.
  • Tracking of on going regulatory activities to ensure:Appropriate follow-up of on-going activities with company Affiliates (submissions and approvals). Run monthly reports to identify upcoming activities.
  • Keep the Manufacturing Site Regulatory Affairs Fields up to date (Planned Submission Month, Support Status, etc)
  • Keep the List of Countries in date base updated
  • Review Good Manufacturing Practices documentation to ensure compliance with current regulatory commitments,
  • Ensure all coporate policies related to health, safety and environment are understood and followed in relation to the role.
  • Subject Matter Expert on the legalization and consularization of documents.

Basic Requirements:  
Education and Experience  
  • Graduate in Chemistry, Pharmacy or other background in life science.
  • Exemplary English oral and written communication skills (C1/ Advanced or equivalent).