Job description

Job Responsibilities;

• 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

Job Requirements;

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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