Regulatory Affairs Associate

Xeolas; Dublin; On-site; EUR 40,000 - 50,000; Full time

Job summary

A pharmaceutical company based in Dublin is seeking a Regulatory Affairs Associate to support regulatory publishing and submission activities. This role involves compiling regulatory dossiers, preparing and submitting documentation, and conducting quality reviews. The ideal candidate will have a Bachelor's degree in Health Sciences and 1-3 years of experience in the regulatory field. Strong attention to detail and organizational skills are essential. This permanent full-time position offers the opportunity to grow within a dynamic regulatory function.

Qualifications

• 1-3 years of experience in the pharmaceutical regulatory industry.
• Solid understanding of applicable regulations and guidance documents.

Responsibilities

• Support the compilation of regulatory dossiers for submissions.
• Assist in the preparation and submission of regulatory documentation.
• Conduct quality reviews of submission documents.
• Manage project workflows throughout the submission lifecycle.

Skills

Regulatory affairs principles

Attention to detail

Organizational skills

Ability to manage multiple priorities

Education

Bachelor's degree in Health Sciences or a related field

Job description

Dublin, Ireland - Permanent Full Time Role

Xeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals. We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets. As we expand our in-house capabilities, we are seeking a skilled Regulatory Affairs Associate to support our regulatory publishing and submission activities.

Role Overview

The Regulatory Affairs Associate will play a key role in supporting the preparation, publishing, and submission of regulatory documentation for both new applications and lifecycle maintenance of existing products. This position offers an excellent opportunity to contribute to a growing regulatory function within a dynamic and innovation-driven organization.

Reporting To

Regulatory Affairs Manager

Key responsibilities

• Support the compilation of regulatory dossiers for EU and Rest of World (ROW) submissions.
• Assist in the preparation and submission of variations, responses to regulatory queries, and other regulatory documentation.
• Support with administrative tasks such as CPP, GMP and MIA request.
• Perform operational tasks related to document authoring, including formatting, editing, reviewing, publishing, and archiving (both paper and electronic).
• Conduct quality reviews of submission documents to ensure accuracy, completeness, and compliance with regulatory standards.
• Manage project workflows throughout the submission lifecycle, ensuring timelines are met and proactively addressing issues or resource needs.
• Review of R&D documents for under development projects.
• Stay informed of evolving regulatory requirements and submission standards.
• Undertake additional tasks as assigned by the Regulatory Affairs Manager.

Qualifications & Experience

• Bachelor's degree in Health Sciences or a related field, or equivalent relevant experience.
• 1-3 years of experience in the pharmaceutical regulatory industry.
• Solid understanding of regulatory affairs principles, applicable regulations, and guidance documents.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.

Apply for this Job

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