Regulatory Affairs Officer

Regulatory Affairs Officer - Pharmaceutical - Permanent - Cheshire

Our client is a leading pharmaceutical manufacturer. At present they are seeking a Regulatory Affairs Officer on a permanent basis at their site in Cheshire.

Responsibilities:
As a Regulatory Affairs Officer you'll help to ensure products are legally compliant and meet customers quality and regulatory expectations, in accordance with Good Manufacturing Practice, human and veterinary medicines regulations and Food Safety Legislation.

Key Tasks:

• Assessing new materials and components for their compliance to appropriate regulatory standards.
• Risk assessing new legislation against current products and materials.
• Generation of documents and statements to support customers registrations and exports.
• Documentation preparation and active participation in PQRs.
• Manage and facilitate licence and batch specific variation processes
• Complete customer questionnaires regarding company regulatory and quality capabilities.
• Ensure supplier documentation is maintained and adequately tracked.
• Perform and manage COSSH assessments for new and existing materials.
• Actively engage with customers with regards regulatory issues concerns or opportunities.
• Support Sustainability, Environmental and Health and Safety initiatives.