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Responding to, and circulating internally, MHRA Recall Alerts and notifications. * Review supplier and customer related documents to aid in the approval of suppliers and customers. Key Competencies ...

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 ...

Ensure GDP compliance and manage the MHRA WDA license. * Tackle quality challenges, oversee audits, and ensure processes align with industry standards. * Collaborate with leadership to promote ...

Knowledge of GMP and GDP regulations and MHRA/HPRA expectations.

Experience working with and under MHRA guidelines - previous auditing experience would be advantageous. * Able to work in a fast-paced, dynamic and commercially driven environment. Benefits/package ...

Proven experience with FDA, EMA, and/or MHRA processes, including submissions and negotiations. * Expertise in biologics, ATMPs, vaccines, or small molecules. * Advanced degree in life sciences (MSc ...

Up-to-date knowledge of the ABPI, PAGB codes, MHRA and other relevant international regulatory bodies * Understanding of the NHS/ international health systems and broader health environment

Up-to-date knowledge of the ABPI, PAGB codes, MHRA and other relevant international regulatory bodies * Understanding of the NHS/ international health systems and broader health environment