About Xeolas

Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Senior Specialist as we expand.

Overall Role Objective

The Regulatory Affairs Senior Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development.

Reporting To

Manager Regulatory Affairs

Requirements

• Preparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions).
• Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA
• Review of data intended for submission and advise regarding any deficiencies or issues.
• Ensure on-time submissions for all quality/ safety related changes for assigned projects.
• Preparation and submission of translated texts to EU/Non-EU countries
• Update of databases and systems for all products (in-line with current SOPs)
• Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
• Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
• Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
• Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.
• Embrace Xeolas values and behaviour
• Support the Xeolas business by participating in project teams to support departmental initiatives.
• On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager.