Medical Writer

Medical Writer -Kent

6 month contract - hybrid

PAYE

£17.67 per hour

Atrium is looking for an experienced a Regulatory Submissions Specialist ,to support the coordination, preparation and delivery of global and regional regulatory submissions within a highly regulated pharmaceutical environment.

Key Responsibilities

• Coordinate regulatory submission activities across assigned products and regulatory procedures.
• Project manage the preparation and delivery of electronic and paper regulatory submissions.
• Work closely with regulatory teams, country representatives and external partners to ensure submission requirements and deadlines are achieved.
• Coordinate dossier content, translations and submission timelines across regional and national markets.
• Ensure regulatory submissions are delivered to Health Authorities and appropriately archived.
• Support document management, publishing and submission-ready dossier preparation.
• Interpret regulatory guidelines and translate them into operational requirements.
• Identify and implement improvements to regulatory submission processes.
• Ensure submissions meet internal QC/QA and compliance standards.
• Act as an SME for specific dossier types and submission processes.
• Identify and escalate issues that could affect submission timelines or delivery.

Experience Required

• Previous experience working with regulatory submissions within the pharmaceutical industry.
• Hands-on experience with electronic submission build and dossier management.
• Understanding of regional and national regulatory dossier requirements.
• Strong project coordination/project management experience.
• Knowledge of regulatory filing guidelines and the drug development process.
• Experience working with document management, publishing or archival systems.
• Excellent attention to detail and ability to manage multiple deadlines.
• Strong communication skills and experience working with cross-functional/global teams.