About the Role
The Regulatory Specialist will focus on study start-up activities, preparing and submitting regulatory documents, maintaining compliance, and working cross-function, to enable rapid trial activation in various countries.
Responsibilities
- Prepare and compile regulatory submissions for clinical trial applications in multiple jurisdictions.
- Ensure all study start-up documentation adheres to local regulatory requirements and internal standards.
- Coordinate with country-specific authorities to obtain approvals for clinical trial initiation.
- Track submission timelines and follow up on outstanding regulatory queries or requests.
- Maintain up-to-date regulatory intelligence on evolving requirements across regions.
- Collaborate with legal and ethics teams to finalize informed consent forms and study protocols.
- Support the development and maintenance of regulatory templates and standard operating procedures.
- Liaise with external vendors and local partners to gather necessary country-specific documentation.
- Verify completeness and accuracy of regulatory packages prior to submission.
- Manage electronic trial master files related to regulatory start-up activities.
- Respond to regulatory agency questions and requests during the review process.
- Monitor changes in regulations that may impact study timelines or requirements.
- Assist in the preparation of responses to regulatory observations or deficiencies.
- Ensure compliance with ICH-GCP, local laws, and company policies throughout the start-up phase.
- Support inspection readiness for regulatory authorities by maintaining accurate records.
- Facilitate communication between internal teams and health authorities as needed.
- Provide regulatory input during protocol development and feasibility assessments.
- Track and report on regulatory milestones and submission status across studies.
- Assist in training team members on regulatory processes and updates.
- Ensure timely renewal of regulatory approvals throughout the study lifecycle.
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with flexibility based on project needs
Team
Collaborative, fast-paced environment focused on global clinical trial execution
Why Join Us
- Opportunity to work on diverse global clinical trials with a dedicated team.
- Supportive culture that values professional development and work-life balance.
- Exposure to innovative therapies and regulatory strategies across therapeutic areas.
- Growth potential within a growing organization focused on clinical excellence.
Travel Requirements
Occasional travel may be required for training, audits, or team meetings.
Available for qualified candidates requiring sponsorship
