Regulatory CMC strategy manager
ICON plcEngland, United Kingdom
Posted May 18, 2026
Full Time
About the Company
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Job Description
We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs team at ICON. The Senior Manager, CMC Strategy is responsible for global CMC regulatory strategies and activities for a large Pharma portfolio through clinical development, market launch and product lifecycle management.
Requirements
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in global pharmaceutical/biotechnological drug development
- Proven knowledge of the global regulatory CMC environment
- Demonstrated experience in authoring and managing components of regulatory submissions
- Good knowledge of global regulatory requirements
- Ability to support regional and local regulatory affairs teams
Benefits
- Annual leave entitlements
- Health insurance offerings
- Competitive retirement planning offerings
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits
