ICON plc is a world-leading healthcare intelligence and clinical research organization committed to fostering an inclusive environment driving innovation and excellence
Job Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization committed to fostering an inclusive environment driving innovation and excellence.
As a Senior Manager, Regulatory Affairs, you will provide RA CMC support to clients and act as a trusted partner representing the Regulatory Affairs Department in business development activities.
ICON offers competitive salary and a range of benefits focused on well-being and work-life balance, including health insurance, retirement planning, and global employee assistance programs.
Matching Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization committed to fostering an inclusive environment driving innovation and excellence.
Skills & Requirements
Must-have
Regulatory Affairs CMC expertise
Knowledge of global regulatory requirements
Experience with drug development stages
Authoring Module 3 CTD documents
Client advisory and regulatory support
Business development in regulatory affairs
Nice-to-have
Experience with peptides and proteins
Strong organizational and multitasking skills
Excellent communication and presentation skills
Problem-solving and interpersonal skills
Inclusive and diverse work culture
Key Requirements
Minimum 7 years regulatory affairs experience
Supervisory experience
Pharmaceutical/CRO industry experience
Experience in regulatory strategies and document writing
Experience with marketing authorization applications
Experience with clinical trials and post-licensing activities