Senior Regulatory Affairs Specialist - CMC

About the Role

Our client is seeking a detail-oriented and experienced Senior Regulatory Affairs Specialist with a focus on Chemistry, Manufacturing, and Controls (CMC) to join their growing team in Leeds . This hybrid role offers a dynamic environment where you will be responsible for developing and executing regulatory strategies for the submission of CMC documentation to global health authorities. You will play a crucial part in ensuring our client's pharmaceutical products meet all regulatory requirements from development through to post-approval. This position requires a strong understanding of pharmaceutical manufacturing processes and regulatory guidelines.

Key Responsibilities

• Prepare, review, and submit CMC regulatory documentation (e.g., INDs, NDAs, MAAs) to global health authorities.
• Develop and implement regulatory strategies for CMC aspects of drug development programs.
• Liaise with internal departments (e.g., R&D, Manufacturing, Quality Assurance) to gather information and ensure regulatory compliance.
• Interpret regulatory guidelines and provide strategic advice to project teams on CMC regulatory requirements.
• Manage post-approval CMC changes and supplements, ensuring timely submissions and approvals.
• Act as a key contact point for health authorities on CMC-related inquiries.

Requirements

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology) or equivalent. Master's degree preferred.
• Minimum of 5 years of experience in regulatory affairs, specifically focused on CMC for pharmaceuticals.
• In-depth knowledge of ICH guidelines and global regulatory requirements for CMC (e.g., FDA, EMA, MHRA).
• Experience with regulatory submission processes, including eCTD format.
• Strong analytical, organizational, and written/verbal communication skills.
• Ability to work effectively in a hybrid environment and collaborate with cross-functional teams.

Benefits

• Competitive salary and performance-based bonus structure.
• Comprehensive health, dental, and vision benefits.
• Hybrid work model providing flexibility between office and remote work.
• Generous holiday allowance and pension scheme.
• Opportunities for professional development and continued learning.