Reg. Affairs Specialist

Job description

My client a leading Cork company urgently require a Senior Regulatory Affairs Specialist

Key duities of the role will include (but not limited to) :

  • Review, approve and monitor all artwork changes for contracted & commercialized labels.
  • Ensures compliance with labelling requirements in accordance with FDA labelling updates.
  • Exposure to analysis & comparison to make decisions regarding labelling content. 
  • Management of adverse event reporting, including review approval & submission of safety reports
  • Lifecycle management of Safety Data Exchange Agreements, third party and internal PV procedures
  • Experienced wth data preparation for quarterly board decks & management review
  • Auditing of supplier PV groups and/or PV service providers.
  • Lifecycle management of supplier Safety Data Exchange Agreements
  • Operate medical communications line in accordance with supplier SDEAs
  • Maintain appropriate and current records
  • Monitor and interpret regulations to evaluate the impact on the business.

What you'll need .

  • 4+ FDA regulated pharmaceutical experience with knowledge of:

    • Knowledge of current US/EU regulatory requirements. Third level Degree.
    • An understanding of directives, standards, & guidelines & the ability to implement appropriately.

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