Regulatory Affairs Specialist - CMC

About the Role

Our client, a dynamic pharmaceutical company, is seeking a detail-oriented Regulatory Affairs Specialist to join their Chemistry, Manufacturing, and Controls (CMC) regulatory team in Reading . This role is essential for ensuring that our pharmaceutical products meet stringent regulatory requirements throughout their lifecycle, from development to post-approval. You will be responsible for preparing and submitting CMC documentation to health authorities worldwide, collaborating closely with R&D, manufacturing, and quality assurance departments to ensure compliance and facilitate timely product approvals. This is a fantastic opportunity for a regulatory professional to contribute to bringing vital medicines to patients in a challenging and rewarding environment in Reading , working within a company committed to scientific integrity and regulatory excellence.

Key Responsibilities

• Prepare, review, and submit CMC regulatory documentation (e.g., IND amendments, NDAs, MAAs) to global health authorities.
• Maintain regulatory compliance for commercial products, including managing post-approval changes and annual reports.
• Liaise with internal departments (e.g., R&D, Manufacturing, Quality Assurance) to gather information and ensure consistency in regulatory submissions.
• Interpret regulatory guidelines and assess their impact on CMC strategies and documentation.
• Support regulatory agency inspections and respond to deficiency letters related to CMC aspects.
• Track and communicate regulatory intelligence pertaining to CMC requirements in key markets.

Requirements

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.
• Minimum of 3 years of experience in regulatory affairs , with a strong focus on CMC .
• Solid understanding of global CMC regulatory requirements (e.g., FDA, EMA).
• Experience with preparing and submitting regulatory dossiers.
• Strong analytical, organizational, and written communication skills.
• Ability to work effectively in a cross-functional team environment in Reading .

Benefits

• Competitive salary and opportunities for performance-based increases.
• Comprehensive health and wellness benefits package.
• Retirement savings plan with employer matching.
• Support for professional development and continuous learning.
• A collaborative workplace culture that values contributions and encourages growth within the CMC regulatory affairs field in Reading .