Connecting...

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.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.