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Senior Regulatory Affairs Officer - 12 month role

Job description

Senior Regulatory Affairs Officer

12 Month Contract

Responsibilities:

  • 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

 

Requirements:

  • 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.

 

Benefits:

Flexitime, Performance Bonus, Paid Holidays, Parking, Life Assurance, Pension Fund

 

 

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