Senior Country Approval Specialist

Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy. Serve as primary contact for investigators and local regulatory authorities to ensure timely management of submissions. Develop country-specific Patient Information Sheet/Informed Consent form documents and maintain accurate trial status information in the database.

Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience comparable to 5+ years in regulatory submissions. Strong knowledge of regional/national regulatory guidelines and excellent negotiation skills.

null