Regulatory Operations Associate

• Hub Submission Manager (Regulatory Operations)
• 6-month contract, PAYE
• Location: Sandwich, UK – Hybrid
• Rate: Up to £32.35 per hour

Overview

A fantastic opportunity for a regulatory operations professional to manage the planning, coordination, and delivery of regulatory submissions across global markets. Working within a highly regulated pharmaceutical environment, you will ensure regulatory dossiers are prepared, built, and submitted to health authorities in line with business-critical timelines.

This role sits within a global regulatory team and requires close collaboration with internal stakeholders, country affiliates, and external partners to support both new product applications and lifecycle management activities.

Key Responsibilities

• Lead the coordination and delivery of regional and national regulatory submissions.
• Manage submission timelines, ensuring all milestones and regulatory deadlines are met.
• Prepare, compile, and technically build electronic regulatory dossiers (eCTD).
• Coordinate document receipt, publishing, translation activities, and submission logistics.
• Partner with regulatory teams, affiliates, and third-party providers to ensure submission requirements are understood and delivered.
• Support Health Authority submissions and ensure accurate archival of all regulatory documentation.
• Monitor submission progress, identify risks, and proactively resolve issues.
• Drive continuous improvement initiatives to enhance submission processes and operational efficiency.
• Interpret regulatory requirements and support implementation of new processes and standards.
• Act as a subject matter expert for submission systems, tools, and processes.
• Mentor colleagues and support knowledge sharing within the team.

Requirements

• Degree in Life Sciences, Pharmacy, Business, Information Technology, or equivalent experience.
• Experience supporting regulatory submissions within the pharmaceutical, biotechnology, or life sciences industry.
• Strong understanding of regulatory dossier structures and global submission requirements.
• Knowledge of electronic submissions (eCTD) and publishing systems.
• Proven project management and coordination skills.
• Ability to manage multiple projects and competing priorities simultaneously.
• Excellent organisational skills with strong attention to detail.
• Experience working within a highly regulated environment.
• Strong communication and stakeholder management skills.
• Ability to work effectively across global and cross-functional teams.

Desirable Experience

• Experience with global regulatory operations and submission planning.
• Knowledge of drug development and regulatory affairs processes.
• Multilingual capabilities.
• Experience driving process improvements and implementing new technologies or systems.

For more information, please reach out to [email protected]