RA CMC Consultant

We're seeking a RA CMC Consultant to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. As a Senior Manager, Regulatory Affairs, you will provide RA CMC support to our clients and work closely with them to achieve their goals. The ideal candidate will have advanced understanding of regulatory work and specialist RA CMC knowledge, as well as experience in different stages of drug development and global requirements in major regions.

Requirements

• Demonstrate advance understanding of regulatory work and possess specialist RA CMC knowledge
• Familiar with global requirements in major regions (including USA, EU, Japan and China)
• Experience of different stages of drug development (including LCM)
• Capable of authoring Module 3 CTD documents (optional competency)
• In-depth proven regulatory affairs expertise with a minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience
• Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail
• Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

Benefits

• Various annual leave entitlements
• A range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits