About the Role
This role leads the development and execution of regulatory and start-up activities for international clinical studies, managing cross-functional coordination to accelerate trial initiation and maintain adherence to local and international regulations.
Responsibilities
- Lead the preparation and submission of regulatory documents to health authorities in multiple jurisdictions
- Develop and manage timelines for country-specific regulatory processes and site activation
- Collaborate with local regulatory experts to ensure compliance with evolving requirements
- Oversee the collection and verification of essential site documents for clinical trial initiation
- Serve as primary point of contact for sponsors and internal teams on regulatory start-up matters
- Ensure accurate and timely entry of regulatory data into trial management systems
- Review informed consent forms for alignment with regional legal and ethical standards
- Monitor regulatory changes across key markets and advise project teams accordingly
- Coordinate with ethics committees and institutional review boards for approvals
- Manage central and local regulatory inspection readiness for assigned studies
- Support the development of start-up plans and country-specific activation strategies
- Track and report on start-up metrics including site activation timelines
- Provide guidance on regulatory requirements during protocol development phases
- Train team members on regulatory processes and documentation standards
- Ensure proper archiving of regulatory records in compliance with retention policies
- Liaise with legal and compliance departments to address regulatory risks
- Assist in the evaluation of new countries for trial feasibility from a regulatory standpoint
- Maintain up-to-date knowledge of ICH-GCP, FDA, EMA, and other regional guidelines
- Optimize start-up processes to reduce study launch delays
- Contribute to the improvement of templates, tools, and standard operating procedures
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with flexibility for remote and office-based work
Team
Part of a global clinical operations team supporting complex trial execution
Why Join Us
- Opportunity to work on innovative clinical trials across therapeutic areas
- Supportive environment that values professional development and growth
- Collaborative culture focused on operational excellence and patient impact
Travel Requirement
Up to 10% travel may be required for site visits, meetings, or training sessions
No visa sponsorship available for this position
