Regulatory Affairs Specialist - CMC

About the Role

Our client seeks a detail-oriented Regulatory Affairs Specialist with a focus on Chemistry, Manufacturing, and Controls (CMC) to join their team in Manchester . You will play a crucial role in preparing and submitting regulatory documentation to health authorities worldwide, ensuring compliance with global pharmaceutical regulations. This position is vital for facilitating the timely approval and lifecycle management of our client's innovative pharmaceutical products. The successful candidate will demonstrate a strong understanding of CMC requirements and possess excellent technical writing skills, contributing to the successful navigation of complex regulatory landscapes and ensuring product quality and safety.

Key Responsibilities

• Prepare, review, and submit CMC regulatory documentation (e.g., INDs, NDAs, MAAs) to global health authorities.
• Interpret and apply global regulatory guidelines and requirements to CMC strategies.
• Liaise with internal departments (e.g., manufacturing, quality control, R&D) to gather necessary information for regulatory submissions.
• Manage regulatory submission timelines and ensure adherence to agreed-upon schedules.
• Respond to queries from health authorities regarding CMC aspects of submissions.
• Maintain regulatory documentation and ensure compliance throughout the product lifecycle.

Requirements

• Bachelor's degree in chemistry, chemical engineering, pharmacy, or a related scientific field.
• Minimum of 4 years of experience in regulatory affairs , with a specific focus on CMC.
• In-depth knowledge of global CMC regulations and guidelines (e.g., FDA, EMA).
• Experience with regulatory submission software and electronic publishing tools.
• Strong technical writing and communication skills, with the ability to clearly articulate complex scientific information.
• Ability to manage multiple projects simultaneously and meet strict deadlines.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunity to work on diverse and innovative pharmaceutical products .
• Generous annual leave and company holidays.
• Professional development opportunities and training programs.
• A collaborative team environment within a well-established pharmaceutical organization in Manchester .