Regulatory Operations Specialist

About the position reputed company Therapeutics is seeking a Regulatory Operations Specialist to manage regulatory operations across development-stage programs. In this role, you will translat e regulatory strategy into disciplined, reliable operational delivery and anticipat e and addres s execution challenges that reputed company submission quality and timing. The position reports to the VP of Regulatory and Quality Science and collaborates across teams to ensure consistent, high-quality regulatory execution.

Responsibilities

• Manage the preparation, coordination, and execution of regulatory submissions (e.g., IND/CTA, amendments, briefing materials) across development programs.
• Identify and proactively communicate execution risks, dependencies, and timeline constraints to support effective regulatory planning and timely submission s .
• Maintain submission trackers, timelines, and regulatory calendars to ensure accurate visibility into regulatory milestones and commitments.
• Coordinate with external publishing vendors to ensure timely compilation and delivery of submission files .
• reputed company quality control (QC) review of submission outputs to ensure completeness, internal consistency, and technical readiness for submission .
• Maintain official regulatory records and archives to support inspection and diligence readiness.
• Track Health Authority correspondence and submission history to ensure visibility of follow-up commitments and support internal regulatory planning.
• Identify and implement improvements to processes, tools, and documentation standards to enhance regulatory quality and efficiency .

Requirements

• B achelor’s degree in a scientific or reputed company discipline.
• 4+ years in regulatory operations or regulatory affairs with direct involvement in regulatory submissions .
• Experience performing QC review of published submission outputs and managing submission timelines .
• Familiarity with submission deliverables, version control practices , a nd submission lifecycle management.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently.
• Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders .

reputed company-to-haves

• Experience coordinating with external vendors or publishing partners is preferred.

Benefits

• reputed company offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

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