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Regulatory Affairs Specialist

3 weeks ago

Dublin, Dublin City, Ireland Xeolas Full time
Xeolas Overview
Xeolas is an Irish-owned specialty pharmaceutical company with a strong presence in Dublin, Ireland. We have a team of over 70 employees who work together to develop and manufacture innovative patient-friendly pharmaceutical products for international markets.

Job Description:
The Regulatory Affairs Senior Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs, including existing licensed products and those under development. The key objective is to ensure compliance with health authority expectations for pharmaceuticals in EU, US, and ROW regions.

  • 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.

Key Skills/Experience Requirements
To excel in this role, you should have:
  • A Master's/Bachelor's degree or equivalent in Science/Technology/Pharmacy.
  • Minimum 5 years of experience in Regulatory Affairs.
  • Strong understanding of health authority expectations for pharmaceuticals in EU, US, and ROW regions.
  • Excellent organisation skills, time management skills, and attention to detail.
  • Strong critical thinking and problem-solving abilities.
  • Effective interpersonal and communication skills.

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