Regulatory Manager

📋 Description

• • The Regulatory Manager provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.
• • Day-to-day responsibilities include compiling, coordinating, and reviewing applications to Regulatory Authorities (such as CTA/IND, annual reports, routine amendments, scientific advice meetings, orphan designations, pediatric planning, and marketing applications), developing and reviewing regulatory documents for submission, serving as a representative of Global Regulatory Affairs at project team and business development meetings, overseeing and coordinating Regulatory Affairs Specialists, maintaining project plans and regulatory intelligence tools, and providing ICH GCP guidance and training to internal and external clients.
• • PFM Asset Management (operating as Precision Medicine Group) is a global provider of clinical development and regulatory solutions, supporting pharmaceutical and biotechnology companies in bringing safe and effective therapies to market through expert regulatory strategy and execution.
• • In this role, the individual will deepen expertise in global regulatory requirements, lead cross-functional initiatives, mentor junior regulatory staff, influence regulatory strategy for new study opportunities, and contribute to corporate quality initiatives while ensuring compliance and high-quality submissions across clinical development programs.