Regulatory Specialist – Clinical Studies

About the role

The Regulatory Specialist will coordinate, prepare, and review clinical regulatory documents, ensuring compliance with local, regional, and international regulations. This role supports study start‑up, ongoing submissions, and regulatory oversight for clinical trials across multiple sites.

Key responsibilities

• Support study start‑up and regulatory activities, obtaining and maintaining ethics and regulatory approvals.
• Create master regulatory packages for submissions to regulatory agencies and ethics committees.
• Prepare and submit ongoing notifications, safety updates, and periodic reports to central and local IRBs/ECs.
• Review Master Informed Consent Forms for country‑specific requirements and develop localized ICFs.
• Assemble essential document packages for sites, verify completion, and facilitate site submissions to IRBs.
• Track performance metrics, manage risk mitigation actions, and provide status updates in study team meetings.
• Provide regulatory guidance, escalate timeline or compliance concerns, and stay current on agency changes.
• Assist study teams during internal audits, mock inspections, and actual regulatory inspections.

Required profile

• Bachelor’s degree in a related field or equivalent experience.
• Minimum 3 years of regulatory experience in a pharmaceutical or CRO environment.
• Extensive knowledge of FDA GCP‑ICH guidelines and local regulatory requirements.
• Experience coordinating site regulatory activities is a plus.
• Strong administrative and clerical competency, with ability to handle confidential information.

Required skills