Regulatory CMC Strategist

ICON plc

2d

About The Position

Regulatory CMC Strategist 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 Manager, Regulatory Strategy to join our diverse and dynamic team. As a Manager, Regulatory Strategy at ICON, you will play a pivotal role in shaping and implementing strategic regulatory plans to the development and approval of inNvative treatments and therapies. Your expertise will be crucial in navigating complex regulatory landscapes and ensuring compliance with global regulatory requirements.

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 kNwledge 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.

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.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager