Due to the growth of the business, they are looking to add to their Regulatory Affairs Manager ideally with project management experience. This position will support regulatory activities associated with EU post-licensing activities and development, including the development of regulatory strategy, regulatory activities for clinical trials... 

 

• Participate in the appropriate project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
• Ensure that Product Quality Reviews have been carried out and reported by the CMO(s) and that any trends have been identified and corrective and/or preventative actions implemented 
• To carry out a review and approval of validation protocols and reports during Technical Transfer 
• Prepare and maintain Technical Quality Agreements with third-party contractors 
• Ensure that an appropriate level of product batch record reviews are carried out at the CMO facilities
• Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO control processes in order to maintain GMP and regulatory compliance 

 Position Requirements but not limited to:

• A Life Science degree or equivalent
• A broad experience of working within the pharmaceutical industry of which several years will have been operating in a senior QA Management position at a manufacturing site.
• Excellent working knowledge of international GxPs, especially in  the interpretation of MHRA and FDA requirements, for the manufacture, control, and distribution of commercial product and clinical trial materials
•  knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments)
• knowledge of QC and Stability chemical analytical testing techniques for solids and semi-solids
• Familiar with the regulatory requirements for validation activities as applied to manufacture and packaging processes, analytical methods, cleaning procedures, .computerised systems
• Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines

 

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