Regulatory Affairs Specialist

About the Role

Our client is seeking a highly organized and knowledgeable Regulatory Affairs Specialist to join their team in Leeds . This role is essential for ensuring that all company products meet the stringent regulatory requirements of national and international health authorities. You will be responsible for preparing and submitting regulatory documentation, maintaining compliance, and advising internal teams on regulatory strategy. This is a critical position for someone passionate about navigating the complex regulatory landscape of the pharmaceutical industry and contributing to getting vital medicines to market.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTAs, MAAs, NDAs) to health authorities worldwide.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulations.
• Monitor and interpret evolving regulatory guidelines and advise on their impact on company products and processes.
• Liaise with regulatory agencies during the review process and respond to queries.
• Maintain regulatory databases and ensure timely updates of product registration information.
• Support regulatory aspects of product lifecycle management, including post-approval changes.

Requirements

• Bachelor's degree in a life science, pharmacy, or related field.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs .
• Demonstrated experience in preparing and submitting regulatory applications.
• In-depth knowledge of global regulatory requirements and submission processes.
• Excellent analytical, written, and verbal communication skills.
• Ability to work independently and manage multiple projects effectively in a dynamic environment.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Pension scheme and life assurance.
• Opportunities for professional development and continuous learning.
• A collaborative team environment within our Leeds office.