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Job Description
Xeolas, an Irish-owned speciality Pharmaceutical company, seeks an experienced Regulatory Affairs Senior Specialist to join its team in Dublin, Ireland.
We are looking for a highly skilled professional with a strong background in regulatory affairs to support the company's growth and expansion. The ideal candidate will have a deep understanding of health authority expectations for pharmaceuticals in EU, US, and ROW regions.
Key Responsibilities:
- Preparation and maintenance of high-quality dossiers for marketing authorisation applications, responses to health authority questions, and post-approval submissions.
- Submission of CPP/Manufacturing authorisation requests to health authorities.
- Review of data intended for submission and advise on 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 to establish effective communication and relationships 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 on the status and progress of assigned projects, identifying potential problems or delays, and possible solutions.
- Maintain an awareness of regulatory requirements and use this information to optimise departmental procedures and processes.
- Embrace Xeolas values and behaviour.
- Support the Xeolas business by participating in project teams to support departmental initiatives.
Requirements:
- Masters/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, time management, and attention to detail skills.
- Strong critical thinking and problem-solving abilities.
- Excellent interpersonal and communication skills.
- Experience in dealing with multiple stakeholders, both internal and external.