Regulatory Affairs Associate

Job Description

We are seeking a Regulatory Affairs Associate to support our medical research projects in Luton. The successful candidate will manage regulatory submissions and ensure compliance with UK regulatory bodies.

Responsibilities

• Conduct regulatory assessments and gap analysis for ongoing projects.
• Support in preparing responses to regulatory inquiries.
• Facilitate training for staff on regulatory processes and updates.
• Assist in the coordination of regulatory submissions during audits.
• Review and update compliance documentation as necessary.

Requirements

Education

• Bachelor's degree in a relevant field
• Master's degree in Regulatory Affairs is preferred

Experience

• 3+ years of relevant experience in regulatory affairs within the healthcare sector.

Technical Skills

• Regulatory Submissions
• Risk Management

Soft Skills

• Project Management

Certifications

• Certified Regulatory Affairs Specialist (CRAS)

Languages

• English: Fluent

Advantageous

• Proficiency in regulatory software and tools: Experience using software for compliance monitoring and document management.
• Experience with electronic submissions: Knowledge of submitting documents electronically to regulatory agencies.

Benefits

• Health insurance covering medical, dental and vision
• Retirement savings plan with employer contribution
• Support for continuous professional development
• Work-life balance initiatives

Company Culture

• Diversity and Inclusion: We are committed to fostering a diverse and inclusive work environment.
• Continuous Learning: We encourage professional development and continuous learning for all staff.