Dublin, Republic of Ireland
5 months ago
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.
- 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
- 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 firstname.lastname@example.org