Regulatory Affairs Specialist

Regulatory Affairs Specialist - I

Pay: £25-£26.39 p/h + holiday + pension

Hybrid

Contract 12month PAYE

Atrium (EMEA) are supporting a global biopharma company we are looking for a detail-driven Regulatory Affairs Specialist to join a leading pharmaceutical organisation.

This is an exciting opportunity to work within Global Regulatory & International Operations, supporting the delivery of regulatory submissions across multiple regions.

You will play a key role in managing dossier development and submissions to global Health Authorities, working in a fast-paced, highly regulated environment with cross-functional international teams.

Key Responsibilities

• Lead and coordinate regulatory submission activities for assigned products and markets
• Manage end-to-end submission processes, including planning, document collection, technical build and delivery
• Deliver high-quality electronic and paper submissions in line with global regulatory requirements
• Liaise with global project teams, country affiliates and stakeholders to ensure alignment on timelines and submission requirements
• Oversee translation activities, dossier compilation and submission logistics
• Ensure compliance with regulatory guidelines, timelines and quality standards
• Support process improvements and efficiencies across submission workflows
• Act as a subject matter expert, mentoring colleagues and sharing best practices
• Identify and escalate risks/issues impacting submission timelines

Key Requirements

• Experience in regulatory submissions within the pharmaceutical industry
• Degree or equivalent experience in Life Sciences, Pharmacy
• Experience within pharmaceutical or regulatory environments preferred
• Strong understanding of Regulatory submission processes and Dossier structure and lifecycle management
• Proven ability to coordinate activities in a regulated environment
• Experience with electronic submission systems and tools
• Excellent project management and organisational skills
• Knowledge of the drug development process
• Degree (or equivalent experience in Life Sciences, Pharmacy

Why apply:

• Work with a globally recognised pharmaceutical leader
• Exposure to international regulatory submissions and markets
• Opportunity to develop SME-level expertise in regulatory operations
• Collaborative, fast-paced and impact-driven environment