Senior Manager, Regulatory Affairs

Join to apply for the Senior Manager, Regulatory Affairs role at Rapport Therapeutics
.

At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy a healthier, more fulfilling life. Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs) – a component of neuronal receptor complexes that regulate receptor assembly and function. This precision approach has the potential to revolutionize small molecule therapies.

We are excited about the potential of our lead program, RAP-219, whose first indication targets focal epilepsy with planned trials for neuropathic pain and bipolar disorder.

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.

• 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 ensuring 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

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

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down‑to‑earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We’re bicoastal. Whether you’re in the lab full‑time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

We get it. Compensation is an important part of your offer.…