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, 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 in project team and business development meetings, overseeing Regulatory Affairs Specialists, maintaining project plans and regulatory intelligence tools, and providing ICH GCP guidance and training.
• • PFM Asset Management (operating as Precision Medicine Group) is a clinical solutions provider focused on supporting drug development through regulatory expertise, project management, and scientific services, with a commitment to quality, compliance, and innovation in bringing medicines to market.
• • In this role, the individual will deepen expertise in global regulatory requirements, lead cross-functional initiatives, mentor junior staff, influence regulatory strategy, and contribute to corporate quality initiatives while ensuring compliance across international clinical programs.