Overview In this role you will lead the end-to-end regulatory submission process across Prime Medicine's pipeline, coordinating with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure timely, high-quality filings. You will guide cross-functional teams through INDs/CTAs, BLAs/MAAs, and updates, while maintaining compliant publishing and document systems. You'll drive schedules, mitigate risks, and support health authority interactions to advance patient-focused therapies. This is a chance to shape regulatory strategy in a cutting-edge gene-editing context and collaborate across global teams. Compensation / Benefitsmedical, dental, and vision insurancelife insurance401(k) matchequity programs ResponsibilitiesLead end-to-end planning and execution of regulatory submissions (INDs/CTAs, BLAs/MAAs, amendments, annual reports, briefing packages)Develop and maintain integrated regulatory timelines, track milestones, identify critical-path risks, and drive mitigation plansCoordinate cross-functional content with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partnersSupport health authority meetings preparation, including briefing books, logistics, minutes, and action item trackingTrack and coordinate responses to health authority information requests across teamsManage regulatory publishing and document management systems to meet eCTD and technical standardsMaintain regulatory operations SOPs and tracking systems, identify and implement process improvementsAssist in vendor and budget oversight for publishing and translation services Key requirementsBachelor's degree in life sciences, regulatory affairs, or related field7+ years in regulatory affairs or regulatory operations in pharma/biotechExperience managing IND/CTA and BLA/MAA submissions from planning through filingStrong knowledge of eCTD structure, regulatory publishing tools, and document management systems (e.g., Veeva Vault RIM)Proven project management skills with ability to handle multiple programs and prioritiesExcellent written and verbal communication with strong cross-functional collaboration and stakeholder managementHigh attention to detail and quality mindsetcross-functional collaborationattention to detailstrong communicationeCTD knowledgeregulatory publishing toolsdocument management systems
Not specified in the original listing.
Not specified in the original listing.
