CMC Author
ICON plcMadrid, Community of Madrid, Spain • England, United Kingdom
Posted March 2, 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
ICON plc is seeking a Senior Manager, Regulatory Affairs CMC to join its diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Requirements
- CMC knowledge
- Advance understanding of regulatory work and specialist RA CMC knowledge with different modalities
- Familiarity with global requirements in major regions
- Different stages of drug development
- Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support
Benefits
- Various annual leave entitlements
- Health insurance offerings
- Competitive retirement planning offerings
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits