Regulatory Affairs Executive - Belfast

Job summary

We are a leading consultancy firm with offices on three continents, and we are building our specialist team of consultants with knowledge of medical devices, diagnostics, and combination products. Our team works closely with a wide range of clients from start-ups to established companies, helping them navigate the complex regulatory landscape and bring innovative products to market.

Responsibilities

• Plan and prepare strategies for post-approval activities, such as variations, renewals, market expansions, and annual reports.
• Evaluate change controls and provide regulatory insights on quality changes in production and quality control.
• Review study reports (like process validation, stability studies, analytical method validation) from quality control and production to ensure everything meets regulatory standards.
• Work with teams across manufacturing, supply chain, quality control, quality assurance, and other regulatory departments to coordinate submission preparation.
• Write or review submission content to make sure it aligns with regulatory requirements (for variations and health authority questions).
• Identify, escalate, and manage risks related to regulatory procedures and activities.

Requirements

• Strong understanding of CMC and post-approval regulatory requirements.
• Knowledge of regulatory processes, systems, and guidelines (like quality control, stability, process validation, and comparability studies).
• Excellent written and spoken English.
• Proficiency in a local language (depending on location: French, Italian, or German).
• Understanding of biological processes and qualification/validation principles

Job description