Job title: global regulatory compliance specialist
job description
as a key member of the site activation team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.
* deliver high-quality results at the country level while adhering to project requirements and applicable country rules.
* monitor financial aspects of the project and track milestone progress in real-time, providing rationale for delays and assisting with contingency plans.
* review and comply with standard operating procedures (sops) and work instructions (wis), keeping training records updated and ensuring timesheet compliance.
required skills and qualifications
* proven experience in regulatory compliance and site activation.
* excellent communication and problem-solving skills.
* able to work independently and as part of a team.
benefits
* competitive salary and benefits package.
* opportunities for professional growth and development.
* collaborative and dynamic work environment.
others
responsible for one or more of the following country-level functions:
* local submissions specialist — follows project direction from the designated csa and sam; may serve as a point of contact for the sam/pm during start-up; compiles/reviews essential document packages for site activation and may collect documents from sites.
* prepares and submits central ec, local ec, ra, and other local regulatory authority applications; prepares ongoing submissions and amendments as required, with oversight from the ssu country manager.
* liaises between investigational sites and functional leads; oversees site activation end-to-end at country/site level.