Regulatory Affairs Specialist - CMC

About the Role

Our client is seeking a detail-oriented Regulatory Affairs Specialist with expertise in Chemistry, Manufacturing, and Controls (CMC) to join their team in Portsmouth . This office-based role is integral to ensuring that our pharmaceutical products meet all necessary regulatory standards for development, manufacturing, and marketing approval. You will be responsible for preparing and submitting high-quality CMC documentation to health authorities worldwide. This is a key position contributing to the successful launch and lifecycle management of our innovative medicines.

Key Responsibilities

• Prepare, review, and submit CMC regulatory documentation (e.g., INDs, NDAs, MAAs, variations) to global health authorities.
• Liaise with internal departments (e.g., R&D, manufacturing, quality assurance) to gather and consolidate CMC information.
• Ensure compliance of regulatory submissions with current CMC guidelines and regulations.
• Respond to queries from health authorities regarding CMC aspects of submissions.
• Maintain regulatory submission archives and track submission status and approvals.
• Contribute to the development of regulatory strategies for new product development and lifecycle management.

Requirements

• Bachelor's or Master's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific field.
• 3-5 years of experience in regulatory affairs, with a focus on CMC aspects of pharmaceutical development.
• Strong understanding of global CMC regulatory requirements and submission formats (e.g., CTD).
• Experience with regulatory submission software and electronic filing systems.
• Excellent technical writing skills and ability to interpret complex scientific data.
• Meticulous attention to detail and strong organizational skills.

Benefits

• Competitive salary and annual bonus.
• Modern office facilities and a collaborative work environment.
• Comprehensive benefits package including health, dental, and life insurance.
• Generous pension scheme.
• Opportunities for professional development and attending industry conferences.