Senior Regulatory Associate in Letchworth

We are seeking a Senior Regulatory Associate to support and deliver regulatory projects across UK and EU markets, providing high-quality regulatory support and submissions within a fast‑paced consultancy environment. This role is ideal for a regulatory professional with experience managing regulatory activities across multiple procedures who is looking to further develop their strategic, project management, and client‑facing capabilities within a collaborative team.

The opportunity

You will support the delivery of regulatory projects across a range of products and procedures, preparing and reviewing regulatory submissions, contributing to regulatory strategy, and ensuring projects are delivered compliantly and on time. You will work closely with clients, internal stakeholders, and regulatory authorities while supporting junior colleagues and contributing to business development activities.

Key responsibilities

• Identify, interpret, and apply relevant UK, EU, and US regulations and guidance to support project compliance
• Prepare, review, and manage high-quality regulatory submissions with minimal supervision
• Review documentation for accuracy, consistency, and completeness
• Contribute to regulatory recommendations and SME strategies for client projects
• Prepare submissions including CTAs, modifications, MAAs, variations, Scientific Advice requests, PIPs, and Orphan Drug applications
• Support regulatory projects, including liaison with regulatory authorities under supervision
• Monitor project risks, timelines, and action logs, proactively identifying and escalating issues
• Support project planning and stakeholder management to ensure successful project delivery
• Assist with budget management and resource planning where applicable
• Participate in business development activities including scoping calls, proposal support, and follow‑up actions
• Analyse regulatory changes and assess their impact on projects and business activities
• Mentor junior team members on routine tasks and support knowledge sharing within the team
• Ensure all activities are delivered in line with Quality Management requirements and company values.

About you

• Previous hands‑on experience in preparation and management of regulatory submissions including CTA submissions in the EU and/or UK and agency interactions.
• Experience of submissions of other clinical development procedures (PIPs, ODD, Scientific advice) and/or post‑marketing activities is advantageous
• Good understanding of national and EU regulatory procedures
• Ability to contribute to regulatory strategy and interpret relevant legislation, guidance, and procedures
• Strong analytical skills with the ability to review complex datasets and identify inconsistencies or risks
• Understanding of scientific and regulatory environments
• Strong organisational and project management skills, including prioritisation and timeline management
• Excellent written and verbal communication skills with the ability to build strong working relationships
• Collaborative and team‑oriented approach with accountability for individual contributions
• Commercial awareness and understanding of consultancy business environments
• Ability to mentor and support the development of junior colleagues
• Degree in Life Sciences, Pharmacy, or equivalent
• Proficient in Microsoft Office applications
• Eligible to work in the UK; fluent in English.