Senior Director, Regulatory Strategy Program Lead

The ideal candidate for this role is based in Boston, MA with onsite presence Monday-Wednesday; this role is also open to remote candidates.

Your impact:

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.

Your day-to-day:

• 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.

Must-Haves:

• 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.

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 $275,000 to $300,000. 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.