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Regulatory Affairs Team Lead

Location: Dublin North, Dublin
Salary: Negotiable
Posted: 8 months ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice
Contact name: Gillian McMurrough
Contact email: gillian.mcmurrough@hrmrecruit.com

Job description

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 teams workload and activities
  • Lead the preparation of Module 1 documentation, ensure submissions and deficiency questions are properly handled and in 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 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 Gillian McMurrough at HRM on +353 87121 3548 for a confidential discussion.

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Gillian Mc Murrough

Associate Director - Science

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