Senior Regulatory Affairs Officer
12 Month Contract
- The Senior regulatory Affairs Officer will maintain approved marketing authorisation (MA) dossiers through submission of variations, renewals, follow-up measures and PSURs
- They will prepare submissions while collaborating with other departments and partner companies
- They will also prepare responses to regulatory authority queries
- Responsible for the publishing of regulatory submissions
- Reviewing and approving of product artworks to ensure compliance with the relevant MA
- Interactions with Corporate office/ partner companies and provision of documentation required to support the MAs they have responsibility for
- They will maintain the manufacturing licence by submission of any necessary variations to the HPRA
- Regulatory compliance activities relevant to the manufacturing site, including review of change controls and GMP documentation
- Clear communication of the regulatory status of products to internal and external stakeholders
- The next Senior Regulatory Affairs Officer will have a degree in a scientific discipline and 3 years experience in pharmacetuical regulatory affairs.
- They will have working knowledge of European pharmaceutical regulations, Directives and guidelines.
Flexitime, Performance Bonus, Paid Holidays, Parking, Life Assurance, Pension Fund
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