Regulatory Affairs Specialist

Jacksonstone Recruitment Ltd; Wicklow; On-site; EUR 42,000 - 60,000; Full time

Job summary

Jacksonstone Recruitment Ltd is seeking a Regulatory Affairs/Quality Assurance professional to support regulatory, quality and operational activities related to registration, maintenance and compliance of products and processes.

You will prepare documentation for product registrations, respond to regulatory queries, maintain statutory requirements, analyse LIMS data for stability reports, review CoAs, support audits and risk assessments, and drive continuous improvement across the QMS with a

Qualifications

• GMP, quality and regulatory requirements understood and applied.
• Excellent attention to detail and strong documentation skills.
• Ability to interpret complex regulatory documentation accurately.
• Strong organisational and time-management abilities.

Responsibilities

• Prepare and maintain documentation required for registration of products and processes.
• Prepare responses to regulatory queries from authorities.
• Define and maintain statutory requirements for new products and changes.
• Retrieve and analyse LIMS data to support regulatory and stability reports.
• Review and approve Master QC and Master Process documentation, including CoAs.
• Support departments with regulatory documentation queries and ensure compliance.
• Assess regulatory impact of changes to registered documentation.
• Collaborate to prepare and maintain the Site Master File.
• Prepare Product Quality Reviews (PQRs) in line with legislation and requirements.
• Participate in internal and external audits and support audit activities.
• Participate in QMS risk assessments.
• Review APQCs weekly, and maintain related registration tables.
• Review CoAs for accuracy and regulatory compliance.
• Provide quality and regulatory input in site performance meetings.
• Maintain focus on compliance, data integrity, and continuous improvement.

Skills

Regulatory affairs

Quality management

Documentation control

Data analysis

GMP compliance

Cross-functional collaboration

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.
• 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.