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 reputed company into disciplined, reliable operational delivery and anticipat e and addres s execution challenges that reputed company submission reputed company and timing. The position reports to the VP of Regulatory and reputed company Science and collaborates across teams to ensure consistent, high-reputed company 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 reputed company constraints to support effective regulatory planning and reputed company 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 reputed company compilation and delivery of submission files . • reputed company reputed company 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. • reputed company 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 reputed company and efficiency . Requirements • B achelor’s degree in a scientific or reputed company discipline. • 4+ years in regulatory operations or regulatory affairs with reputed company 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 reputed company convey operational considerations and collaborate effectively with reputed company 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 reputed company insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. Apply tot his job Apply To this Job