CMC Author

CMC Author- Homebased in UK, Spain, Germany or France

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Manager, Regulatory Affairs CMC to join our 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.

What you will be doing:

•  CMC knowledge - Ideal candidate would author Module 3 CTD documents and participate in strategic discussions and act as RA specialist..

• You will have advance understanding of regulatory work and possess specialist RA CMC knowledge with different modalitie...