Regulatory Affairs Specialist - CMC

About the Role

Our client seeks a dedicated and knowledgeable Regulatory Affairs Specialist with expertise in Chemistry, Manufacturing, and Controls (CMC) to join their team, working remotely and supporting operations based in Leeds . This role is vital for ensuring that all pharmaceutical products meet stringent regulatory requirements across global markets. You will be responsible for preparing and submitting CMC-related regulatory documentation, liaising with health authorities, and ensuring compliance throughout the product lifecycle. This is an excellent opportunity for a regulatory professional to make a significant impact from a remote setting, contributing to timely approvals and market access for essential medicines.

Key Responsibilities

• Prepare, review, and submit CMC sections of regulatory dossiers (e.g., INDs, NDAs, MAAs).
• Interpret and apply global regulatory guidelines (FDA, EMA, etc.) to CMC strategies.
• Liaise with manufacturing, quality assurance, and R&D departments to gather necessary CMC information.
• Respond to queries from regulatory authorities regarding CMC submissions.
• Maintain regulatory compliance for all registered products throughout their lifecycle.
• Monitor changes in the regulatory landscape and assess their impact on CMC documentation.

Requirements

• Bachelor's or Master's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs, with a strong focus on CMC.
• Thorough understanding of CMC requirements for drug product development and manufacturing.
• Experience with regulatory submission formats and eCTD.
• Excellent analytical and problem-solving skills.
• Proficiency in remote collaboration tools and strong written/verbal communication skills.

Benefits

• Competitive salary and remote work flexibility.
• Home office setup allowance.
• Comprehensive health, dental, and vision benefits.
• Generous paid time off and holiday schedule.
• Opportunities for professional development and training in regulatory affairs.