Regulatory Operations Specialist

Role Summary

Our client is eeking a Regulatory Operations Specialist to support regulatory operations across development-stage programs. In this role, you will translate regulatory strategy into disciplined, reliable operational execution and proactively identify challenges that may affect submission quality and timing.

This position reports to the VP of Regulatory and Quality Science and works cross-functionally with internal teams and external partners to ensure consistent, high-quality regulatory submissions and documentation.

Key Responsibilities

Regulatory Submission Management

• Manage the preparation, coordination, and execution of regulatory submissions, including INDs/CTAs, amendments, and briefing materials across development programs.
• Coordinate with external publishing vendors to ensure timely compilation and delivery of submission files.
• Perform quality control (QC) review of published submission outputs to ensure completeness, internal consistency, and technical readiness for submission.

Operational Planning & Execution

• Identify and proactively communicate execution risks, dependencies, and timeline constraints that may impact regulatory submissions.
• Maintain submission trackers, timelines, and regulatory calendars to ensure visibility into regulatory milestones and commitments.

Documentation & Regulatory Records

• Maintain official regulatory records and archives to support inspection readiness and due diligence activities.
• Track Health Authority correspondence and submission history to ensure visibility of follow-up commitments and support internal regulatory planning.

Process & Systems Improvement

• Identify opportunities to improve regulatory processes, tools, and documentation standards to enhance submission quality and operational efficiency.

Qualifications

Education & Experience

• Bachelors degree in a scientific or related discipline.
• 4+ years of experience in regulatory operations or regulatory affairs with direct involvement in regulatory submissions.

Technical Expertise

• Experience performing QC review of published submission outputs and managing submission timelines.
• Familiarity with submission deliverables, version control practices, and submission lifecycle management.

Core Skills

• Strong organizational skills and attention to detail with the ability to manage multiple priorities simultaneously.
• Strong written and verbal communication skills, with the ability to clearly convey operational considerations and collaborate effectively with internal and external stakeholders.
• Experience coordinating with external vendors or publishing partners is preferred.