Senior Regulatory CMC strategy manager

Senior Regulatory CMC strategy manager focuses on bachelor's degree in a relevant scientific discipline or healthcare-related field.

Skills and requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Requires an extensive experience in global pharmaceutical/biotechnological drug.
• Demonstrated experience in authoring and managing components of regulatory submissions.
• Demonstrated ability to develop and implement global CMC regulatory strategies.

Confirmed role details

• We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs team at ICON this is a fixed term contract initially until 31st March.
• A range of health insurance offerings to suit you and your family’s needs.
• Plan with confidence for the years ahead.
• Competitive retirement planning offerings to maximize savings.

Candidate fit

• Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval.
• Manages the CMC regulatory strategy of high quality and compliant regulatory CMC.
• Advises on regulatory strategies, solutions to scientific problems and interpretation of.