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Regulatory Submission Manager

As Regulatory Submission Manager, you will be expected to coordinate the overall submission activities relating to a given product or portfolio. You will be working with a cross-functional team at the Dublin site.

Company/Culture

This global leader in the provision of specialty pharmaceuticals is known worldwide for its friendly and welcoming environment. You will be part of a team that sits globally, giving you the chance to gain unrivalled experience from those you work with both on-site and off. This is a company where flexible working hours ensure employee time is both valued and protected, competitive salary and benefits packages ensure talent is recognised and continuous professional development allows employees to grow.

Day-to-Day

As Regulatory Submission Manager, your duties will include:

  • Planning and preparing the regulatory submissions pipeline for life-cycle maintenance activities.
  • Authoring and reviewing Module 1 documentation.
  • Coordinating the review of published outputs.
  • Coordinating responses to health authority questions and commitments.
  • Monitoring progress performance of Regulatory Submission plans

Skills/Requirements:

  • BSc in a Life Science or Pharmacy.
  • 3 years of experience working within Regulatory Affairs (in different areas e.g. Labelling, CMC, Submissions)
  • Solid project management skills
  • Understanding of CMC and Labelling components

Apply with an up to date CV if you're interested or give me a call to find out more!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales