Senior Director, Regulatory CMC

Rapport Therapeutics•Boston, MA

16h•$265,000 - $285,000•Hybrid

About The Position

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. 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 healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials in primary generalized tonic-clonic seizures (PGTCS) and bipolar disorder. The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are! This role is based in Boston, MA with onsite presence required Monday-Wednesday

Requirements

Bachelor’s degree in a scientific discipline; advanced degree preferred.
12+ years of Regulatory CMC experience in biotech or pharma, including significant late-stage and global registration experience.
Strong understanding of CMC development, manufacturing, analytical, quality, and regulatory considerations.
Experience developing global Regulatory CMC strategies across multiple stages of development.
Experience leading or supporting CMC content for INDs/IMPDs and marketing applications, including CTD Module 3.
Experience contributing to at least one NDA or MAA, preferably through submission and Health Authority review.
Strong knowledge of FDA, EMA, ICH, and global CMC requirements.
Experience supporting CMC Health Authority interactions and responses.
Strong cross-functional leadership, communication, and collaboration skills.
Comfortable working across multiple programs in a fast-paced, evolving environment.

Nice To Haves

Neuroscience experience.
Small molecule and/or long-acting injectable experience.
NDA/MAA and commercialization experience.
Prior technical CMC experience.

Responsibilities

Combine strategic leadership with hands-on execution to shape Regulatory CMC strategy, advance our pipeline, and build the function for scale
Develop and execute global Regulatory CMC strategies across development programs from early development through commercialization.
Serve as the Regulatory CMC lead on cross-functional teams, providing strategic guidance across CMC development, manufacturing, analytical, quality, and lifecycle activities.
Lead the preparation, review and coordination of CMC content and strategy for global regulatory submissions, including clinical and marketing applications.
Support interactions with FDA, EMA, and other global health authorities, including meeting preparation and regulatory responses.
Evaluate CMC changes and provide practical, risk-based regulatory recommendations that support compliance, timelines, and business goals.
Partner closely with CMC, Technical Operations, Quality, Supply Chain, and Program Management to advance programs and ensure regulatory readiness.
Build and develop the Regulatory CMC function, establishing effective processes and capabilities to support late-stage development, submissions, and commercialization.
Stay current on evolving global CMC regulations and drive continuous improvement across Regulatory CMC practices.