Regulatory CMC Strategist

Responsibilities

• Develop and implement global regulatory strategies for clinical development programs.
• Partnership with cross-functional teams to provide regulatory guidance throughout the product development lifecycle.
• Interpret and communicate regulatory requirements to internal stakeholders.
• Contribute to the preparation and submission of regulatory documents, including INDs, NDAs, and regulatory briefing documents.
• Monitor regulatory changes and assess their impact on product development strategies.
• Engage with regulatory agencies to facilitate product approvals and address regulatory inquiries.

Requirements

• Bachelor's or advanced degree in a relevant scientific or regulatory discipline.
• Proven experience in regulatory strategy within the pharmaceutical or CRO industry.
• In-depth knowledge of global regulatory requirements for drug development and submissions.
• Strong analytical and strategic thinking skills, with the ability to navigate complex regulatory scenarios.
• Excellent communication skills, fostering partnership across diverse teams.

Benefits

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

About the Company

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.