REGULATORY AFFAIRS ADMINISTRATOR

Univet Limited; Cootehill; On-site; EUR 32,000 - 42,000; Full time

Job summary

Univet Limited is seeking a Regulatory Affairs Administrator to join our veterinary pharmaceutical team in Ireland. You will provide administrative and operational support across Regulatory Affairs, with a focus on artwork reviews, rejections, SCARs, reports, and pharmacovigilance activities.

This role offers exposure to regulatory documentation, audits, and interactions with multiple departments, supporting a career in Regulatory Affairs, Quality or Pharmacovigilance.

Qualifications

• Experience with regulatory documentation workflows is desirable.
• Ability to work across Regulatory Affairs, Quality and Pharmacovigilance.
• Strong written and verbal communication skills.

Responsibilities

• Coordinate artwork review and approvals for veterinary products.
• Document and manage regulatory rejections and responses.
• Track SCARs and CAPAs and liaise with stakeholders.

Skills

Regulatory affairs

Attention to detail

Organised

Communication

Tools

Microsoft Word

Excel

Adobe Acrobat

Microsoft 365

Job description

We are seeking a highly organised and detail-oriented Regulatory Affairs Administrator to join our team within the veterinary pharmaceutical sector.

The successful candidate will provide administrative and operational support across Regulatory Affairs, with particular responsibility for artwork reviews, regulatory rejections, SCARs (Supplier Corrective Action Requests), preparation of reports and supporting pharmacovigilance activities.

This is an excellent opportunity for an individual looking to develop their career within a regulated pharmaceutical environment and gain broad experience across Regulatory Affairs, Quality and Pharmacovigilance.

Key Responsibilities

• Coordinate and support the review and approval of artwork for veterinary pharmaceutical products, ensuring that materials are accurate, compliant and consistent with approved product information.
• Manage artwork review comments, amendments and approvals, ensuring that changes are accurately documented and completed within agreed timelines.
• Support the administration and management of regulatory rejections, including maintaining accurate records, coordinating responses and monitoring actions through to resolution.
• Assist with the management of SCARs (Supplier Corrective Action Requests), including documentation, tracking, follow-up and communication with relevant stakeholders.
• Provide administrative support to Pharmacovigilance activities, including the receipt, recording and tracking of safety information and associated documentation.
• Maintain accurate regulatory databases, trackers, records and filing systems.
• Assist with the preparation, review and organisation of regulatory documentation and submissions.
• Liaise with Regulatory Affairs, Pharmacovigilance, Quality, Marketing, Supply Chain and other departments to support regulatory and compliance activities.
• Assist with audits, inspections and regulatory projects as required.
• Ensure all assigned activities are completed accurately, efficiently and within applicable procedures and deadlines.

About You

The successful candidate will be:

• Highly organised with excellent attention to detail.
• Comfortable working with regulated documentation, processes and procedures.
• A clear and effective communicator, both verbally and in writing.
• Able to manage multiple priorities and work effectively to deadlines.
• Proficient in Microsoft Office, particularly Microsoft Word and Excel.
• Able to work independently while contributing effectively as part of a team.
• Interested in developing a career within Regulatory Affairs, Quality or Pharmacovigilance.

Experience within one or more of the following areas would be advantageous:

• Regulatory Affairs within the pharmaceutical, veterinary pharmaceutical, medical device or healthcare sector.
• Regulatory artwork management or artwork review.
• Managing regulatory queries, deficiencies or rejections.
• SCARs, CAPAs, deviations or Quality Management Systems.
• Pharmacovigilance or adverse event reporting.
• Working within a GxP or other regulated environment.

Full training in veterinary pharmaceutical regulatory requirements will be provided. However, candidates must already possess a very high level of competence in Microsoft Word, Adobe Acrobat and Microsoft 365 applications.

Shortlisted candidates may be asked to complete a practical document-formatting assessment as part of the recruitment process.