Regulatory Affairs Associate

Excellent opportunity to join a medium sized pharma company based in Berkshire

Role

Support Regulatory Affairs across UK and Central & Eastern European markets, ensuring compliance with regulatory requirements and effective lifecycle management of marketed products

Key Responsibilities

• Manage regulatory activities for assigned marketed products and support distributor markets across Central and Eastern Europe.
• Coordinate regulatory stakeholder communications and act as a key liaison between cross-functional teams.
• Support the preparation and submission of regulatory variations and other lifecycle management activities in accordance with applicable regulatory requirements.
• Assist in developing and implementing regulatory operational plans for assigned products and projects.
• Provide regulatory guidance on local procedures, compliance requirements, and best practices.
• Review and support the maintenance of product information, including Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and artwork.
• Maintain regulatory databases, document management systems, trackers, and shared mailboxes to ensure accurate and timely record keeping.
• Contribute to the development, review, validation, and maintenance of Standard Operating Procedures (SOPs) and process documentation.
• Support internal audits by coordinating regulatory documentation and ensuring inspection readiness.
• Manage assigned projects while ensuring data accuracy, consistency, traceability, and compliance with regulatory timelines.
• Collaborate with cross-functional teams to drive process improvements and support continuous compliance initiatives.