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Regulatory Affairs Specialist

Job Seekers Ireland Science Life Science

Job Summary

  • Galway
  • Permanent
  • BBBH782000
  • May 11, 2021
  • Competitive
Job Description

Regulatory Affairs Specialist now required to join a well-known pharmaceutical company based in Galway. Please see below to apply today!

We are now recruiting a Regulatory Affairs Specialist to be part of a dynamic team within a pharmaceutical company based in Galway.

We are looking for individuals who will support and drive the client's Pharma's vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to customers.

In this role you will assist in the process of development of new products, attaining and maintaining Product Licences / Marketing Authorisation for the client's business.

KEY RESPONSIBILITIES:

  • Compilation of VICH regulatory dossiers Parts I-IV for EU National, MRP, DCP and centralized Marketing Authorization (MA) Applications
  • Preparation and submission of renewal applications for existing MA's
  • Preparation and submission of variation applications for existing MA's
  • Review of process validations protocols and reports
  • Review of method validation data and stability
  • Review of Drug Master Files
  • Review of protocols for bioequivalence, residue and efficacy studies and reports
  • Writing of Expert Reports for European MA's
  • Responding to queries raised by the regulatory authorities
  • Artwork review and approval
  • Transfer of data from Regulatory Dept. to QA, QC, Production
  • Responding to customer queries and queries from other departments
  • Timely and accurate preparation of dossiers for submission and response to authority questions
  • Attention to detail in generation of dossier, protocols and reports
  • Ability to work on multiple projects simultaneously
  • Communication skills with external and internal customers

QUALIFICATIONS:

  • 3rd level qualification in relevant discipline
  • Multinational experience (preferable but not essential)
  • 2 years + experience in a similar role, pharmaceutical/healthcare experience would be an advantage.
  • Excellent written and communication skills.
  • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Ailis Dwyer
Ailis Dwyer
  • Consultant | Engineering Recruitment
  • 353 (0) 21 2300300
  • adwyer@morganmckinley.com