This role is based in Boston, MA with onsite presence required Monday-Wednesday
Your impact:Combine strategic leadership with hands-on execution to shape Regulatory CMC strategy, advance our pipeline, and build the function for scale
Your day-to-day:- 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.
Must-Haves:- 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.
Preferred Experience - Neuroscience experience.
- Small molecule and/or long-acting injectable experience.
- NDA/MAA and commercialization experience.
- Prior technical CMC experience.
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. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $265,000 to $285,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. 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 Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.
