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Life Time Quality Records (LTQR): You’ll ensure the robust documentation of all quality activities for full traceability and regulatory compliance across the project lifecycle. Performance Monitoring & Reporting: You’ll track QA/QC KPIs, produce insightful reports for leadership, and recommend t

Regulatory team and help take a breakthrough neuromodulation device through PMA submission and into the market. Playing a key role in FDA Q-Subs and cross-functional regulatory strategy. This is a high-impact opportunity to shape a high-growth regulatory function, work closely with the VP, and ge...

The regulatory team are focused on both regulatory compliance and customer need to ensure products meet the highest standards of quality and commerciality. Managing an effective global regulatory horizon scanning process to ensure our regulatory processes remain future-fit. An experienced regulat...

Are you a hands-on Regulatory Affairs professional with a passion for clinical trials and a drive to grow into leadership? Join a dynamic, fast-paced SME-sized CRO specialising in oncology, where your expertise will shape the future of our expanding Regulatory Affairs team. Clinical trial, study,...

Regulatory responses and briefing documents. Develop and deliver high-quality regulatory documents in line with guidelines. The Role: Senior Regulatory Writer.

The Regulatory Labelling and Artwork Specialist role is part of a project with a leading biopharmaceutical company focused on developing innovative treatments for rare and ultra-rare genetic diseases.

Your new roleRegulatory Submissions & Health Authority Interactions; prepare and submit regulatory applications to the MHRA (UK) and HPRA (Ireland), including variations, renewals, and notifications, manage post-submission queries and liaise directly with Health Authorities to ensure timely appro...