Pharmaceutical Compliance Analyst

Job Description

We are seeking a detail-oriented Pharmaceutical Compliance Analyst to join our medical research team in Luton. You will play a critical role in ensuring that all pharmaceutical practices comply with established regulations, contributing to patient safety and overall quality.

Responsibilities

• Evaluate compliance with GxP regulations and ensure alignment with company policies.
• Assist in the preparation for regulatory inspections.
• Analyze compliance trends and metrics to develop actionable insights.
• Work closely with project managers to ensure all research protocols are compliant.
• Review and approve documentation related to compliance activities.
• Provide guidance on risk assessment and mitigation strategies.
• Develop compliance training materials and conduct training sessions.
• Respond to compliance inquiries and investigate compliance breaches.
• Collaborate with cross-functional teams to implement compliance improvements.
• Contribute to the creation of a compliance culture across the organization.

Requirements

Education

• Bachelor's degree in Pharmacology or a related field
• Postgraduate qualification in Compliance is desirable

Experience

• 3-5 years in a regulatory compliance role within the pharmaceutical industry

Technical Skills

• Compliance Management
• Risk Assessment
• Project Management

Soft Skills

• Teamwork
• Problem Solving

Certifications

• Diploma in Pharmaceutical Compliance
• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent

Advantageous

• Experience with New Product Development compliance: Knowledge of compliance in the context of NPD in the pharmaceutical industry.
• Familiarity with risk management frameworks: Understanding of risk frameworks specific to pharmaceutical operations.

Benefits

• Generous pension scheme
• Flexible working arrangements
• Employee assistance programme
• Support for continuing education and training

Company Culture

• Respect for Diversity: We value diverse perspectives and experiences within our workforce.
• Continuous Improvement: We are committed to continuous improvement in our processes and practices.
• Work-Life Balance: We support work-life balance for our employees through flexible work arrangements.