Regulatory Affairs Specialist

Job Description

We are seeking a Regulatory Affairs Specialist to join our Bristol team. This role involves ensuring that all pharmaceutical products comply with regulatory standards and are developed in accordance with the latest industry guidelines. The successful candidate will coordinate submissions, monitor regulatory changes, and liaise with health authorities to ensure compliance and maintain product registrations.

Responsibilities

• Manage the regulatory submission process from initial notification to final approval.
• Coordinate with international teams for global regulatory strategies.
• Assist in developing and implementing internal audit processes to ensure compliance.
• Keep abreast of industry trends and best practices in regulatory affairs.
• Develop regulatory compliance training materials for new hires.
• Evaluate the impact of regulatory changes on current products and projects.
• Prepare responses to regulatory inquiries and notices.
• Contribute to risk assessments related to product compliance.

Requirements

Education

• Bachelor's degree in a relevant field
• PhD in life sciences or related discipline is a plus

Experience

• 5+ years of experience in regulatory affairs with a focus on pharmaceuticals

Technical Skills

• Regulatory Strategy Development
• Risk Assessment

Soft Skills

• Leadership
• Negotiation

Certifications

• Advanced Regulatory Affairs Certification
• Certified Regulatory Compliance Manager

Languages

• English: Fluent

Advantageous

• Familiarity with Global Regulatory Requirements: Knowledge of regulatory requirements for markets outside the UK and EU.
• Experience in Product Development: Involvement in the lifecycle of pharmaceutical products from development through to regulatory approval.

Benefits

• Comprehensive health benefits including dental and vision
• Flexible working arrangements
• Employee assistance programs
• Continuous learning opportunities

Company Culture

• Diversity and Inclusion: We celebrate diversity and are committed to creating an inclusive workplace for all.
• Continuous Development: Our culture emphasizes continual learning and professional growth for all employees.
• Work-Life Balance: We promote a healthy work-life balance, offering flexible working patterns to our employees.