Job title: Global Regulatory Affairs Manager - CMC

A growing Biopharma in Central Dublin are seeking a Regulatory Affairs Manager with extensive CMC experience. This role will have the opportunity to work on exciting development and marketed products on a global scale.

Responsibilities:

• Management of global regulatory affairs CMC lifecycle documentation
• Coordinating planning, writing and reviewing CMC information for all regulatory compliance submissions and notifications
• Coordinate the preparation of documents and publishing requests to support responses to regulatory agencies
• Support EU, US and global commercial license maintenance

Requirements:

• Minimum of three years Regulatory CMC experience
• Knowledge of FDA, EMA and ICH guidelines.
• Strong understanding of quality management systems including change controls, documentation management systems and experience with electronic Common Technical Document eCTD submission
• BSc minimum

Salary and benefits:

A highly competitive annual salary, bonus, healthcare and pension are on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk