Head of Quality & Regulatory

Proclinical is seeking a Quality and Regulatory Lead to guide and implement regulatory and quality strategies. This role involves managing activities across product portfolios from registration to commercialization in the UK market. The successful candidate will work with pharmaceuticals, medical devices, and nutraceuticals regulatory frameworks, ensuring compliance and fostering a culture of continuous improvement.

Responsibilities:

• 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.
• Lead and develop a small team, fostering a collaborative environment.
• Manage relationships with outsourced providers and ensure service standards.
• Oversee departmental budgets and resources.

Key Skills and Requirements:

• Strong coordination and communication skills.
• Ability to analyse complex regulations and provide guidance.
• Problem-solving skills in regulatory issues.
• In-depth knowledge of UK regulations for drugs, medical devices, and nutraceuticals.
• Commitment to accuracy and proactive approach.
• Experience in a multinational environment.
• Sc. or Pharmacist diploma; additional qualifications in regulatory affairs are beneficial.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.