Regulatory Affairs Operations and Compliance Specialist

On behalf of our client, we are currently recruiting for a Regulatory Affairs Operations and Compliance Specialist to support the operational and compliance activities of the Regulatory Affairs function. This role is responsible for coordinating regulatory submissions, publishing activities, document management, regulatory systems, and compliance processes to support global product registrations. The successful candidate will work closely with cross-functional teams to ensure timely, accurate, and compliant regulatory operations while driving continuous process improvements.

Key responsibilities

• Coordinate, compile, publish, and dispatch regulatory submissions in accordance with global health authority requirements.
• Perform electronic submission publishing activities using Lorenz publishing software, ensuring submissions are technically compliant and submission-ready.
• Maintain and manage regulatory submission documentation, ensuring completeness, accuracy, and version control
• Update and maintain regulatory tracking spreadsheets, submission logs, product registration trackers, and compliance databases.
• Monitor regulatory submission timelines, renewals, commitments, and approvals, ensuring key milestones are achieved.
• Communicate submission status, project updates, risks, and timelines to internal stakeholders and project teams.
• Collaborate with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Clinical, Medical, and Commercial teams to support regulatory activities.
• Support regulatory inspections and internal audits by providing accurate documentation and regulatory records.
• Ensure compliance with internal procedures, GxP requirements, and applicable global regulatory requirements.
• Assist with the development, review, and maintenance of Standard Operating Procedures (SOPs), work instructions, and regulatory processes.
• Produce regulatory metrics, reports, and dashboards to support operational planning and performance monitoring.
• Identify opportunities for process improvements and support the implementation of Provide technical support and guidance on eCTD publishing tools and software.
• Stay updated on changes in regulatory requirements and submission standards.
• Train and mentor staff on eCTD publishing processes and best practices.
• Provide support on dossier compilation activities for EU/ ROW regions
• On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Director.

KEY SKILLS / EXPERIENCE REQUIREMENTS

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, Chemistry, or a related discipline.
• Experience in Regulatory Affairs Operations, Regulatory Compliance, Quality, or a related pharmaceutical, biotechnology, or medical device environment.
• Experience with electronic submission publishing, preferably using Lorenz .
• Strong organisational skills with the ability to manage multiple priorities and meet deadlines.
• Excellent attention to detail and commitment to data accuracy.
• Strong written and verbal communication skills, with the ability to communicate effectively with internal stakeholders.
• Proficiency in Microsoft Office applications, particularly Excel.

Preferred Experience

• Experience supporting submissions to EMA, MHRA, or other international health authorities.
• Familiarity with eCTD publishing requirements and lifecycle management.
• Experience with regulatory systems such as Veeva Vault RIM, Lorenz, MasterControl, GlobalSubmit, or similar platforms.
• Knowledge of GxP, document control, and regulatory compliance requirements.

To apply for this role please call Linda e-mail Linda.Dunne@cpl.com or call on 01 2784703.

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