Regulatory Affairs Manager

Job Description

Join us as a Regulatory Affairs Manager in Luton, where you will ensure our research projects comply with all regulatory standards. You'll be responsible for managing submissions to health authorities and ensuring that our products meet the necessary safety and efficacy criteria. Ideal candidates will demonstrate experience in regulatory strategy, document preparation, and quality assurance.

Responsibilities

• Manage relationships with regulatory authorities and stakeholders.
• Facilitate the smooth submission and approval of regulatory documents.
• Ensure the accuracy and completeness of submission packages.
• Conduct internal audits to ensure regulatory compliance.
• Prepare for and respond to regulatory inquiries and inspections.
• Maintain electronic and paper filing systems for regulatory documents.
• Lead the development of regulatory policies and procedures.
• Advise management on regulatory issues affecting business operations.

Requirements

Education

• Bachelor's in Pharmacy or Life Sciences
• Advanced degree is highly preferred

Experience

• 5+ years in a regulatory role in medical research or pharmaceuticals

Technical Skills

• Regulatory Documentation
• Project Management

Soft Skills

• Organizational Skills
• Interpersonal Skills

Certifications

• ISO 13485 Certification
• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent

Advantageous

• Knowledge of ICH Guidelines: In-depth knowledge of the International Council for Harmonisation guidelines.
• Project Management Professional (PMP) Certification: Professional project management certification will be considered an asset.

Benefits

• Pension contribution scheme
• Flexible working hours and remote work options
• Employee assistance programs for mental health support
• Access to cutting-edge research and development facilities

Company Culture

• Inclusivity: We are dedicated to creating a workplace that embraces diversity and inclusivity.
• Continuous Growth: We provide opportunities for continuous learning and professional growth within the team.