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 with 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 COSHH assessments for new and existing materials. Actively engage with customers regarding regulatory issues, concerns, or opportunities. Support Sustainability, Environmental, and Health and Safety initiatives.
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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 with 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 COSHH assessments for new and existing materials. Actively engage with customers regarding regulatory issues, concerns, or opportunities. Support Sustainability, Environmental, and Health and Safety initiatives.
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