Proclinical is seeking a Quality and Regulatory Lead to guide and implement regulatory and quality strategies. The successful candidate will work with pharmaceuticals, medical devices, and nutraceuticals regulatory frameworks, ensuring compliance and fostering a culture of continuous improvement.
Develop and execute UK regulatory and quality strategies aligned with business goals.
Promote a quality-first culture and continuous improvement.
Provide quality and compliance consultancy to senior management.
Anticipate regulatory changes to identify growth opportunities.
Manage UK regulatory activities, including product registration and compliance.
Ensure MHRA inspection readiness and manage audits.
Lead the quality plan for local product portfolios.
Oversee quality management systems and ensure data integrity.
Address product quality issues and manage local recalls.
Problem-solving skills in regulatory issues.
In-depth knowledge of UK regulations for drugs, medical devices, and nutraceuticals.
additional qualifications in regulatory affairs are beneficial.