Senior Regulatory Affairs Officer

Dublin South  ‐ Onsite
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Description

This company has grown significantly in the last few years and offers excellent progression opportunities.

Principal Duties and Responsibilities of the Senior Regulatory Affairs Officer:
  • Ensure that all new license and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures.
  • Preparation and submission of license and variations to the HPRA, MHRA and other Regulatory Authorities as required.
  • Liaise directly with the regulatory authorities in order to ensure timely approvals and speedy resolution of any issues.
  • Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
  • Ensure up to date files are maintained for all licensed products manufactured and/or released at the company's site.
  • Review of relevant reports to ensure compliance with license details and relevant guidelines and directives.
  • Review and approval of all new and revised master batch documentation, QC specifications and packaging work orders in line with license details and relevant standard operating procedures.
  • Identification, compilation and approval of Regulatory SOP's.
  • Assist in the training of new artwork and regulatory personnel.
  • Set timelines for all license and variation approvals.
  • Work to department KPIs.
  • The Senior Regulatory Affairs Officer will need to have:
  • Third Level qualification a scientific discipline
  • Regulatory experience in a pharmaceutical industry of 3-5 years.
  • EU submission experience will be an advantage, but not essential.


This is a full time, permanent role. An excellent salary of €35,000 - €45,000 + benefits (including 10% bonus) dependent on experience is on offer. For immediate consideration please reply with an updated CV or call Michael Bustamante on .
Start date
11/2015
From
Real Staffing
Published at
03.10.2015
Project ID:
993635
Contract type
Permanent
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