Regulatory CMC Author

Icon • Blue Bell, PA

111d • Remote

About The Position

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.

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.

Responsibilities

• 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 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.

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
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree