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.
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
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.