Regulatory Affairs Officer EMENA

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About the job

  • Spain

Do you have experience in eMC handling and compliance? Are you interested in joining one of the fastest-growing pharmaceutical companies in the world?

Invenia Group is partnered with a leading international pharmaceutical company, that is seeking a Regulatory Affairs Officer to take on this exciting new role covering the EMENA (Europe, Middle East, North Africa) region. This is a fantastic opportunity to join a growing organisation focused on the professional development of its employees.

Role responsibilities:

If successful, you will be responsible for performing routine regulatory intelligence activity and driving procedural change implementation. You will support regulatory compliance activity including the safety change implementation process (safety variations) as well as the following:

  • Publishing of product information over eMC and recording/maintaining/reporting compliance
  • Handling of medical information query for product information content and resolves
  • Coordinate National Phase activity and organise routine meetings to track/ trace the progress of local activities
  • Record variation queries/track the progress and drive timely submission of responses to queries
  • Raise regulatory change control to facilitate variation/ coordinate any deviation arising from routine regulatory compliance activity
  • Check and identify product information and produce supporting documentation for National phase submissions
  • Updates Labelling, a summary of product characteristics, and patient information leaflet
  • Routine review, creation, and maintenance of regulatory standard operating procedures
  • Timely notification of approvals to the co-licensing partners following changes in the product information
  • Prepare regulatory compliance report monthly including compliance report of safety variation/ EMC activities
  • Assist other functions in sharing any regulatory information or documents as required

What we are looking for: 

We are looking for someone educated to a degree level in a life science subject, as well as experience in eMC handling and compliance. You should have good knowledge and understanding of Module 1, and being experienced in pharmaceutical regulatory processes and relevant UK/EU legislation is essential.

You should also have excellent organisation skills, be a strong communicator with exceptional interpersonal skills and work well in a team but also be happy to work autonomously.  

If you are interested in proceeding with this opportunity, please apply and we can arrange a confidential discussion to discuss the position in more detail.