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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