Bristol Laboratories Ltd is one of the leading and fastest growing pharmaceutical companies in the United Kingdom engaged in the development, manufacturing, marketing and distribution of generic medicines, as well as formulation brands. We have state-of-the art manufacturing facilities in Luton & Peterlee.
As a result of continued growth and expansion, we have an excellent opportunity to appoint Regulatory Affairs Officer in Luton
• Compilation of Common Technical Document Dossiers, submissions of applications for Initial national applications/Decentralized procedures (DCP)/Mutual Recognition Procedures (MRP)
• Renewal of Marketing Authorizations
• Handling Change controls for CMC (Chemistry, Manufacturing and Controls) updates in Quality Management System (QMS)
• Compilation and filing of Quality Variations and Safety Variations
• Preparing Quality variations in e-CTD (electronic- Common Technical Document) software
• Responding to Queries from regulatory agencies
• Maintaining Database for Quality & Safety Variations
• Follow-up with authorities for pending applications
• Follow-up with Customers/Finished product manufacturers/contract manufacturers for technical information
• Preparation/Review of product License Files
• Review of BMRs, Process validation documents, Finished Product Specifications and other documents required for submissions
•Any other function that may be required to fulfill regulatory commitments/filings or data base maintenance of regulatory affairs department.
Knowledge & Skills Required:
* Academic achievement to Post Graduate Degree level in a Science based discipline.
* Experience in Regulatory Affairs in Pharmaceutical industry.
* Firm understanding of Regulatory activities /cGMP/cGLP and QMS procedures in a pharmaceutical manufacturing unit as well as in warehousing and distribution.
* Should have sound knowledge on computer validation
This is a fantastic development opportunity for someone seeking the next step in their management career in a high-profile environment