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Rapport Therapeutics · 1 day ago

Senior Manager, Regulatory Affairs

Boston, MA

Full-time

Hybrid

Senior Level, Lead/Staff

$160K/yr - $180K/yr

8+ years exp

Rapport Therapeutics is dedicated to developing precision neuromedicines aimed at improving patients' lives. The Senior Manager of Regulatory Affairs will lead regulatory execution for global Phase 3 clinical trials and ensure successful interactions with regulatory authorities.

BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine

Responsibilities

Assist in the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) to regulatory authorities

Manage and contribute to major and routine regulatory submissions, as assigned, including amendments, responses to questions from health authorities, and ensure timely updates to regulatory documents

Conduct in-depth regulatory research to propose strategic advice on regulatory matters

Stay up-to-date with regulatory guidelines, policies, and best practices related to clinical trials and drug development

Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance

Contribute to the development and continuous improvement of regulatory affairs processes and best practices

Lead the preparation and coordination of responses to health authority questions (FDA, EMA,PMDA, etc.) in collaboration with cross-functional teams

Participate in the planning and execution of health authority meetings, ensuring alignment on regulatory strategy and documentation quality

Partner closely with cross functional teams to ensure regulatory deliverables align with overall study timelines and objectives

Coordinate with CROs and external vendors to ensure consistent regulatory compliance across global trial sites and submissions

Track submission and approval status globally, providing regular updates and reports to leadership

Qualification

Regulatory Affairs experienceGlobal CTA submissionsIND maintenanceRegulatory guidelines knowledgeRegulatory submission softwareProactive attitudeManage prioritiesInterpersonal skills