Pharmaceutical Regulatory Specialist

Job Description

We are seeking a detail-oriented Pharmaceutical Regulatory Specialist to join our team in Luton. The ideal candidate will have a deep understanding of regulatory processes and compliance in the pharmaceutical industry. You will play a key role in ensuring that our projects meet all necessary guidelines and standards, supporting our mission to bring safe and effective medicines to market.

Responsibilities

• Assist in the creation of submission-ready documents for regulatory approvals.
• Develop and implement regulatory policies and procedures.
• Review product labelling and advertising for compliance.
• Contribute to the development of risk assessment strategies.
• Support the regulatory aspects of product recalls if necessary.
• Engage with stakeholders to ensure alignment on regulatory strategy.
• Attend industry conferences and workshops to enhance knowledge.
• Document regulatory correspondence and reporting.

Requirements

Education

• Bachelor's degree in Pharmacy or related field
• Master's degree in a relevant discipline is a plus

Experience

• 4+ years of direct experience in regulatory affairs within pharmaceuticals

Technical Skills

• Regulatory Submissions
• Risk Assessment
• Pharmaceutical Legislation
• Stakeholder Engagement

Soft Skills

• Problem-solving
• Teamwork

Certifications

• Certified Clinical Research Associate (CCRA)
• Regulatory Compliance Certification

Languages

• English: Fluent

Advantageous

• Expertise in EU regulatory frameworks: In-depth understanding of regulatory processes in the European market.
• Familiarity with ICH guidelines: Knowledge of International Council for Harmonisation standards.

Benefits

• Pension scheme and matched contributions
• Flexible work arrangements including remote options
• Employee wellness programmes
• Regular team-building and social events

Company Culture

• Career Growth: We are dedicated to providing opportunities for career advancement and continuous learning.
• Employee Well-being: We prioritise the well-being of our employees through initiatives that promote work-life balance.