Good understanding of regulatory guidelines (MHRA) QA | Quality Assurance | Quality Assurance Officer | QAO | Quality | Quality Management System | QMS | Electronic Quality Management System | CAPA ...
Maintaining cutting-edge GMP facilities licensed by the MHRA, supporting the manufacture of Advanced Therapy Medicinal Products (ATMPs) and related materials. * Lead disaster management and ...
Overseeing and contributing to the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities like the MHRA, FDA, EMA, and others. * Acting as the ...
Leading relevant agency interactions (EMA and MHRA) * Defining and executing Regulatory strategy * Ensuring products remain compliant with relevant legislation * License maintenance activities ...
Leading relevant agency interactions (EMA and MHRA) * Advising on Regulatory strategy to your line manager * Ensuring products remain compliant with relevant legislation * License maintenance ...
Maintain the required accreditations (UKAS, MHRA,HTA). * Ensure operations are compliant with regulations (eg. HSE, COSHH, GDPR). * Management of staff allocations and monitoring workload to ensure ...
QA | Quality | QC | Quality Control | Lab | laboratory | Micro | Biology | GMP | Good Manufacturing Practice | MHRA
Qualified Person qualification would be desirable Director of Quality | Quality Director | QA Director | Quality Assurance Director | FDA | MHRA | Quality Assurance | Quality | GMP | Good ...
Oversee product registrations across relevant categories (Health Canada, FDA, MHRA, MDR, GPSR) and liaise with partners like the European Responsible Person (EURP) for claims substantiation. * Manage ...
