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.