Regulatory Affairs Manager

We are seeking an experienced CMC Director to lead chemistry, manufacturing and controls activities for a Swiss based client with their portfolio of radiopharmaceutical products. The CMC Director will oversee all CMC operations including process development, technology transfer, validation, quality control and regulatory compliance. This in an interim position for 11 months and candidates must be based in Europe.

Key Responsibilities:

• Provide strategic leadership and direction for CMC activities across the radiopharmaceutical product pipeline from development through commercial manufacturing
• Oversee and direct process development, scale-up, technology transfer and validation activities for radiopharmaceutical manufacturing
• Develop and maintain a robust quality control system including analytical testing, specifications and stability programs
• Ensure radiopharmaceutical manufacturing processes and controls adhere to current GMP regulations and facility requirements
• Author and review CMC documentation for regulatory submissions (INDs, NDAs, DMFs)
• Represent CMC operations on project teams and governance committees
• Collaborate cross-functionally with R&D, Supply Chain, Quality, Regulatory Affairs and external partners/CMOs
• Manage CMC project timelines, budgets and resource allocation across multiple products
• Lead continuous improvement initiatives to enhance operational efficiency and compliance
• Recruit, develop and mentor a team of highly skilled CMC professionals

Requirements:

• B.S. degree in Chemistry, Biochemistry or related discipline required, Ph.D. or M.S. preferred
• Minimum 10 years of CMC experience within the radiopharmaceutical industry
• Extensive expertise in GMP manufacturing processes, controls and regulatory requirements for radiopharmaceuticals
• Strong leadership skills with ability to influence and drive cross-functional teams
• Outstanding problem-solving, root cause analysis and technical writing abilities
• Working knowledge of quality systems and risk management principles
• Excellent verbal and written communication skills
• Prior experience managing direct reports and developing CMC talent

This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely.

By clicking “apply” you will be sending your CV to Matt Gilliam at Barrington James. Matt is a specialist Regulator Affair and CMC recruiter and will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself.

Please call +44 1293776644 if you have any questions, alternatively you can reach Matt on mgilliam@barringtonjames.com