Regulatory Consultant

Role & responsibilities: Demonstrated experience in authoring and reviewing Module 3 CMC sections for post-approval CMC variations and other lifecycle maintenance activities, according to current global regulations and guidelines (EU mandatory +ROW market) Strong experience in review and support the preparation of CMC variation applications (e.g., EU Type IA, IB, II variations; US CBE, PAS; ROW changes). Site Transfer related experience Proven ability to work independently and proactively identify and resolve issues. Strong organizational skills and ability to manage multiple priorities in a deadline-driven environment. Job responsibilities Complete tracking of assigned activities while coordinating with Client stakeholders. Collaborate with cross-functional teams (e.g., Manufacturing, QA, QC, Supply Chain) to collect and verify documentation related to pre or post-approval stages. Represent Syneos in cross-functional regulatory and Client teams meetings. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Understands project budgets, scope of projects, allocated hours, and tracks compliance. Provides operational advice to team and client. Effective communication through email and calls with internal and client stakeholders for updates and clarifications. #J-18808-Ljbffr