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Senior Associate Regulatory Affairs Specialist

Reference ID : NHA92
Category :
  • Science
  • Pharma / Biotech
  • Medical Devices
  • General Manufacturing
Date Posted : Jan 3, 2020
Job Location
  • Leinster
- Dublin
Experience : 4+ Yrs
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 087 0622429
Experienced Reg Affairs Associate required for Dublin based pharma company

Principal Responsibilities

Senior Regulatory Affairs Associate

An opportunity has arisen for a Senior Regulatory Affairs Associate to join the global regulatory team within a leading Dublin based pharmaceutical multinational.

The successful candidate will be responsible for the registration documents procurement, preparation and coordination.

Key Duties:

  • Coordinate legalisation and delivery of registration documents
  • Maintain tracking and organization of documentation
  • Support the site regulatory CMC team
  • Maintain relevant databases, tracking systems and document management processes to support the licenses
  • Work in collaboration of Site RA CMC team and other Global/Regional teams as needed

Qualifications & Requirements

Qualifications and Experience:

  • BSc in Regulatory, Life Science or related discipline
  • 4 years relevant pharmaceutical industry experience
  • Basic knowledge regarding CMC sections of a marketing application
  • Knowledge of GMP and GDP
  • Strong written and oral communication skills

For more information contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie

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