Senior Director, Regulatory Strategy Program Lead

As the regulatory lead for RAP-219 and Bipolar Mania trials, you’ll help shape the path from promising science to a potential treatment for patients. You’ll work closely with the program team to develop regulatory strategies, navigate complex decisions, and translate evolving agency expectations into actionable plans. This is a hands on role that requires both big picture thinking and a willingness to dig into the details, challenge assumptions, and work through problems alongside your colleagues. The goal isn’t just to develop a strong regulatory strategy, it’s to help move a potentially meaningful new treatment forward for patients who need better options.

• Lead regulatory strategy for RAP-219, guiding development from early clinical trials through global filings.
• Lead regulatory strategy for our bipolar mania trials, partnering with cross-functional teams to support trial development, execution and development decisions.
• Translate strategy into action through hands-on regulatory planning, document development, submission preparation, and day-to-day problem-solving.
• Shape program decisions across Clinical, CMC, Nonclinical, and Clinical Pharmacology, balancing regulatory expectations with scientific and patient needs.
• Prepare for and lead health authority interactions, including FDA meetings, and serve as a regulatory point of contact as needed.
• Identify regulatory risks early, develop mitigation plans, and help teams navigate complex decisions.
• Own key submissions, including INDs, CTAs, and NDAs. Ensure high-quality content, global compliance, and effective coordination with external partners.
• Grow and motivate a talented regulatory team, fostering accountability, collaboration, and continuous development.
• Partner with the Head of Regulatory Affairs on strategy, priorities, and key decisions.
• Communicate regulatory strategy and risks clearly to cross-functional teams and senior leadership.
• Stay current on global regulations and health authority expectations, applying new insights to advance our programs.

• Bachelor’s degree in a life science or related discipline.
• 12+ years of experience in the pharmaceutical or biotech industry, with progressive responsibility in regulatory strategy.
• Experience leading regulatory strategy for a development program; neurology or psychiatry and small molecules preferred.
• Demonstrated experience navigating late-stage development and contributing to the preparation and submission of an NDA.
• Experience working with Office of Neuroscience FDA Divisions, including leading health authority interactions.
• Global drug development experience.
• Global clinical trial planning and execution experience
• Confidence to challenge a team when needed and the judgment to know when to defer to others’ expertise.
• Ability to influence cross-functional partners, manage competing priorities, and deliver on program goals in a fast-moving biotech.
• Strong interpersonal skills and alignment with Rapport’s values and culture.
• Exceptional written and verbal communication skills.

• 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.