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- Bachelor's degree in Health Sciences or related field
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仕事内容
Overview
Join Xeolas Pharmaceuticals, a proudly Irish-owned company located in Dublin, with over 70 skilled professionals dedicated to developing innovative and patient-centric pharmaceutical products for global markets. We are expanding our regulatory team and are seeking a Regulatory Affairs Associate to assist in regulatory publishing and submission functions.
Role Summary
The Regulatory Affairs Associate will be instrumental in supporting the preparation and submission of regulatory dossiers for new applications and ongoing product lifecycle maintenance, contributing to a growing and innovative regulatory environment.
Responsibilities
- Assist in compiling regulatory submissions for the European Union and Rest of World markets.
- Contribute to the preparation and submission of variation applications and respond to regulatory enquiries.
- Handle administrative duties related to Certificates of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP) certificates, and Mutual Recognition Procedures (MIA).
- Perform document-related operational activities including authoring, formatting, editing, reviewing, publishing, and archiving both electronic and paper documents.
- Conduct quality reviews to assure submission documents' accuracy, completeness, and compliance with regulatory standards.
- Manage submission project workflows, ensure deadlines are met, and proactively resolve issues or resource needs.
- Review research and development documentation for products under development.
- Keep updated on the latest regulatory frameworks and submission criteria.
- Perform other responsibilities as directed by the Regulatory Affairs Manager.
Qualifications and Experience
- Possession of a Bachelor’s degree in Health Sciences or a related discipline, or equivalent experience in the field.
- Between one to three years of experience working within pharmaceutical regulatory affairs.
- Comprehensive knowledge of regulatory affairs principles and applicable guidelines and legislation.
- Exceptional attention to detail, strong organizational skills, and effective multitasking abilities.
Additional Information
Location: Dublin, Ireland.
Employment type: Permanent, full-time, onsite role.
Applicants are encouraged to submit their cover letter along with a CV via email.