Senior Manager, Regulatory Affairs

Role Summary

The Senior Manager of Regulatory Affairs will be a key member of the team leading the regulatory execution for global Phase 3 clinical trials of RAP-219 and supporting other clinical studies, as assigned. This role will drive global submission planning, coordination, and execution across multiple regions, ensuring successful interactions with regulatory authorities and alignment with global development objectives. The ideal candidate is a proactive, detail-oriented regulatory professional who thrives in a fast-paced, collaborative biotech environment.

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

Qualifications

• Required: Bachelors degree in life sciences or related discipline
• Required: 8+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology
• Required: Proven experience with Global CTA submissions and IND maintenance
• Required: Strong knowledge of regulatory guidelines and clinical trial regulations
• Required: Ability to manage multiple priorities and work in a fast-paced, dynamic environment
• Required: Proficient working with regulatory submission software
• Required: Proactive, self-motivated, and able to work independently
• Required: Strong interpersonal skills and alignment with Rapport‚Äôs values and company culture