Regulatory CMC Author

Manager, Regulatory Strategy

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 with regulatory CMC expertise 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 innovative treatments and therapies. Your expertise will be crucial in navigating complex regulatory landscapes and ensuring compliance with global regulatory requirements.

The role will work with a client focusing on :

• Managing routine CMC authoring and submission activities for an assigned product or product portfolio to assure the preparation of high quality and compliant global regulatory submission
• Maintaining regulatory CMC dossier templates in alignment with current ICH and relevant regional regulatory requirements and standards
• Maintaining a core source file management system to support all global plasma CMC submission activities
• Keeping current on global submission requirements, standards, and formats
• Assuring an effective collaboration with Global Regulatory Affairs CMC Strategists, Global Manufacturing and Global Quality SMEs for the timely preparation and review of regulatory submission documentation
• Acting as liaison with relevant regulatory operations teams (e.g., Publishing)
• Supporting the development of efficient submission authoring and preparation procedures to assure timely completion of submission packages per business and regulatory timelines
• Helping maintain relevant submission-related systems and trackers and assuring that global CMC regulatory submission documentation is consistent in terms of content and aligns with the global dossier templates
• Identifying country-specific submission requirements
• Collaborating with Global Regulatory CMC Strategists to define detailed scope of submissions
• Coordinating document review sessions to collate comments and corrections of drafted documents and prepares the documents for final approval for timely submission

Your Profile

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 :

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.