Senior Regulatory CMC Strategist

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.

What You Will Be Doing

• 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.

Your Profile

• 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.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply