FSP Country Approval Associate
Core
Prepare, review, and coordinate country submissions for clinical trials in alignment with global strategy, supporting site start-up activities and regulatory compliance.
Role type
Associate, clinical trial regulatory submissions
Builds
Country-specific submission packages and study files for clinical trials
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory guidelines knowledge, submission coordination, document preparation, database management, negotiation, medical terminology
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare and review country submissions, coordinate with internal departments for site start-up, maintain trial status databases, assist in developing patient information sheets, manage grant budget negotiations, ensure compliance with SOPs
Seniority
Junior, 0-2 years experience
