Teams at Parexel

Lead regulatory CMC activities for biologics: manage new registrations, lifecycle maintenance and renewals across major markets; author and review global/regional regulatory submissions and MAAs/variations; provide technical guidance, mentor team members, and collaborate cross-functionally with strong independent work capability.

Support clinical trial site activation, maintenance, and close-out by managing TMF/TMF uploads, coordinating trainings, vendor and equipment shipments, assisting with CTMS/EDC updates, tracking site documentation, and ensuring inspection readiness while following ICH-GCP and company SOPs.

The Country Study Operations Manager I ensures study management from startup to closure, overseeing local teams and managing project tasks of moderate complexity. Responsible for coordinating with CROs and stakeholders, they support study delivery and compliance with regulations while identifying risks and implementing solutions for effective trial execution.