Rapport Therapeutics
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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.
Your Impact 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.
Your Day‑to‑Day
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
Must‑Haves
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
What Makes Rapport Special
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.
Your Compensation We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. The hiring range for this role is $160,000 to $180,000. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here – if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Hybrid Work Environment We prioritize in‑person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Tuesday and Wednesday. In January 2026, this will shift to three days a week to create more opportunities for innovation, collaboration, and connection.
Rapport Therapeutics is an equal‑opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
CCPA disclosure notice can be found here.
#J-18808-Ljbffr
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.
Your Impact 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.
Your Day‑to‑Day
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
Must‑Haves
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
What Makes Rapport Special
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.
Your Compensation We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. The hiring range for this role is $160,000 to $180,000. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here – if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Hybrid Work Environment We prioritize in‑person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Tuesday and Wednesday. In January 2026, this will shift to three days a week to create more opportunities for innovation, collaboration, and connection.
Rapport Therapeutics is an equal‑opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
CCPA disclosure notice can be found here.
#J-18808-Ljbffr