- The Senior Regulatory Affairs Officer will approve marketing authorisation documentation through submission of variations, renewals, follow-up measures and PSURs
Prepare responses to regulatory authority queries
Publish regulatory submissions using NextDocs and eCTD Manager software
Maintain manufacturing licence by submission of any necessary variations to the HPRA
The Senior Regulatory Affairs Officer will carry out regulatory compliance activities such as review of change controls and GMP documentation.
Review/ approve product artworks to ensure compliance with the relevant Marketing authorisation
The Senior Regulatory affairs officer will have a relevant degree with 4 years experience in the pharmaceutical industry working in regulatory affairs.
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