Our client is a Global Pharmaceutical group with operations in Ireland, EU and the US. They require an experienced Regulatory Affairs professional to join their Regulatory department on a permanent basis and assist in leading the group.

The Role:

Reporting to the Regulatory Affairs Manager, the RA Team Lead will carry out the following activities:

• Lead the Regulatory Affairs submission team
• Coordinate the team's workload and activities
• Lead the preparation of Module 1 documentation, ensure submissions and deficiency questions are properly handled and in a timely manner with regards to new applications, renewal and variation procedures
• Work collaboratively with other functions across the organisation
• Liaise with external parties, Health Authorities of EU, customers and contract manufacturers

The Person:

In order to be considered you must have the following:

• A third level degree in Science, Engineering or related
• 4-8 years of industry experience, ideally 4 of which in a Regulatory role (preferably within the pharmaceutical sector)
• Supervisory / Team Lead experience - essential
• Excellent knowledge of EU regulatory requirements with a focus on Module 1 documentation and eCTD submissions
• Good understanding of requirements for new applications, variations and renewal processes in European procedures including MRP/DCP
• Eligibility to live and work in the EU

To discover more about this opportunity, apply now or contact Helena Boyle on +353 87336 0953 for a confidential discussion.