Regulatory Affairs Specialist - CMC

About the Role

Our client is looking for a highly organised and knowledgeable Regulatory Affairs Specialist with a focus on Chemistry, Manufacturing, and Controls (CMC) to join their team in Liverpool . This role is essential for ensuring that all product development and manufacturing activities comply with global regulatory standards. You will be responsible for preparing and submitting CMC sections of regulatory dossiers for new drug applications and variations. This position offers a fantastic opportunity to work on diverse projects and contribute significantly to the timely market approval of innovative pharmaceutical products.

Key Responsibilities

• Prepare, review, and submit CMC documentation for global regulatory filings (e.g., INDs, NDAs, MAAs).
• Liaise with internal departments (R&D, Manufacturing, Quality Assurance) to gather necessary CMC information.
• Interpret and apply global regulatory guidelines relevant to CMC requirements.
• Manage regulatory agency questions and facilitate responses related to CMC issues.
• Maintain regulatory compliance for assigned products throughout their lifecycle.

Requirements

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.
• Minimum of 4 years of experience in Regulatory Affairs , with a specific focus on CMC.
• In-depth knowledge of ICH guidelines and regulatory requirements in major markets (e.g., FDA, EMA).
• Experience with regulatory submission software and document management systems.
• Strong analytical, problem-solving, and communication skills.

Benefits

• Competitive salary and performance-related bonus.
• Comprehensive health, dental, and vision benefits.
• Hybrid working arrangement supporting work-life balance in Liverpool .
• Opportunities for professional growth and international regulatory training.
• A collaborative environment focused on bringing life-saving medicines to patients.