About the Role
This role focuses on coordinating regulatory documentation and start-up processes for clinical studies, ensuring adherence to international guidelines and local regulations while supporting efficient trial activation.
Responsibilities
- Prepare and submit regulatory documents to ethics committees and health authorities
- Coordinate the collection and review of essential study documents
- Ensure compliance with GCP, ICH, and regional regulatory requirements
- Manage timelines for study start-up activities across multiple regions
- Liaise with internal teams and external partners to resolve regulatory queries
- Track and report status of regulatory submissions and approvals
- Support the development of study-specific regulatory plans
- Maintain up-to-date knowledge of evolving regulatory landscapes
- Assist in the preparation of clinical trial applications
- Oversee the completion of country-specific start-up requirements
- Verify investigator qualifications and site documentation
- Manage regulatory document archives using electronic systems
- Facilitate communication between sponsors and regulatory agencies
- Identify potential regulatory risks and recommend mitigation strategies
- Ensure proper delegation of regulatory responsibilities to sites
- Support audits and inspections related to regulatory compliance
- Standardize processes for regulatory start-up across studies
- Train team members on regulatory requirements and procedures
- Monitor regulatory timelines and escalate delays
- Collaborate with legal and compliance teams on regulatory strategy
- Maintain regulatory tracking tools and databases
- Ensure accurate translation and notarization of study documents
- Coordinate with central laboratories and pharmacies for regulatory alignment
- Support the implementation of global regulatory standards
- Contribute to continuous improvement of start-up workflows
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model
Team
Part of a global clinical operations team
Why Join Us
- Opportunity to work on innovative clinical development programs
- Supportive environment that values professional growth
- Exposure to diverse therapeutic areas and global regulations
- Collaborative culture focused on operational excellence
- Commitment to advancing precision medicine solutions
Travel Requirements
- Minimal travel may be required for training or meetings
- Most responsibilities can be fulfilled remotely
Not specified
