Regulatory Affairs Specialist

Jacksonstone Recruitment Ltd; Wicklow; On-site; EUR 55,000 - 85,000; Full time

Job summary

Jacksonstone Recruitment Ltd is seeking a regulatory affairs quality professional based in Ireland to support registration, maintenance and compliance of products and processes. You will prepare registration documents, respond to regulatory queries, and ensure updates align with current requirements.

The role involves analysing data from LIMS, reviewing CoAs, supporting audits, and contributing to the Site Master File and QMS risk assessments.

Qualifications

• Understanding of GMP, regulatory and quality requirements.
• Ability to interpret regulatory documentation and maintain compliant records.
• Experience in preparing documentation for product registrations and changes.

Responsibilities

• Prepare and maintain documentation for registration of new and existing products and processes.
• Respond to regulatory queries from authorities.
• Define statutory requirements for new products and changes.
• Retrieve and analyse data from LIMS to support regulatory and stability reports.
• Review and approve QC/CoA documentation.
• Support departments with documentation queries to ensure regulatory compliance.
• Assess impact of changes to registered documentation and regulatory implications.
• Collaborate to maintain Site Master File.
• Prepare Product Quality Reviews (PQRs) per legislation and regulatory requirements.
• Assist in internal and external audits and follow up on actions.
• Participate in QMS risk assessments.
• Review APQCs weekly and maintain related tables.
• Review CoAs for accuracy and compliance.
• Participate in site performance meetings and provide regulatory input.
• Maintain focus on compliance, documentation control and continuous improvement.

Skills

GMP knowledge

Regulatory compliance

Documentation

Analytical skills

Cross-functional collaboration

Attention to detail

Time management

Problem solving

Auditing

Data integrity

Tools

LIMS

Job description

The successful candidate will be responsible for supporting regulatory, quality, and operational activities associated with the registration, maintenance, and compliance of products and processes.

Key responsibilities include:

• Prepare and maintain documentation required for the registration of new and existing products and processes.
• Prepare responses to regulatory queries and requests from relevant regulatory authorities.
• Define and maintain statutory requirements associated with the introduction of new products and changes to existing products.
• Retrieve and analyse data from Laboratory Information Management Systems (LIMS) to support the preparation of regulatory and customer stability reports.
• Review and approve Master Quality Control (QC) and Master Process documentation, including Certificates of Analysis (CoAs).
• Support relevant departments with queries relating to registered documentation and ensure that all documentation remains compliant with current regulatory requirements.
• Assess the impact of changes to registered documentation and ensure appropriate regulatory implications are identified and addressed.
• Work collaboratively with relevant departments to prepare and maintain the Site Master File.
• Prepare Product Quality Reviews (PQRs) in accordance with applicable legislation and regulatory requirements.
• Participate in internal and external audits as required, supporting the preparation, execution, and follow-up of audit activities.
• Participate in relevant Quality Management System (QMS) risk assessments.
• Review Annual Product Quality Complaints (APQCs) on a weekly basis, including maintenance of the Finished Product Registration Table and Packaging Subcontractor Table.
• Review Certificates of Analysis (CoAs) to ensure accuracy, completeness, and compliance with approved requirements.
• Participate in site performance meetings and provide relevant quality and regulatory input.
• Maintain a strong focus on compliance, documentation control, data integrity, and continuous improvement across all activities.

Key Competencies

• Strong understanding of GMP, Quality and Regulatory requirements.
• Excellent attention to detail and documentation skills.
• Ability to interpret technical and regulatory documentation.
• Strong organisational and time-management skills.
• Effective communication and cross-functional collaboration skills.
• Ability to manage multiple priorities and work to deadlines.
• Strong analytical and problem-solving capabilities.
• Proactive approach to identifying compliance risks and supporting continuous improvement.