Associate Director/Director, Regulatory Strategy

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.

About the role

We anticipate hiring for this role in mid-Q4. The preferred location for this role is in Boston, MA with an onsite requirement of Monday-Wednesday every week.

The Associate Director/Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for the bipolar indication of our lead program, RAP-219.

Responsibilities

• Create and implement innovative and effective regulatory strategies to support the development of Rapport late-stage global drug development programs.
• Provide regulatory expertise and advice to cross-functional team members including clinical, clinical pharmacology, and nonclinical.
• Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
• Identify regulatory risks, propose mitigation plans, and communicate impact to senior leadership.
• Serve as the regulatory lead on study teams, as assigned, and provide regulatory guidance regarding clinical development plans, trial design, endpoints, safety requirements, and submission strategy.
• Ensure compliance with local and international submission requirements, manage regulatory CROs as applicable.
• Represent Rapport as the point of contact for regulatory health authorities, as assigned, ensuring exemplary ethics and transparency within the company and with health authorities.
• Lead preparation and execution of interactions with FDA, EMA, and other regulatory agencies including coordinating meeting requests, briefing documents, and responses to regulatory questions.
• Monitor and interpret the evolving global regulatory landscape and advise project teams on potential impact to programs.
• Support portfolio planning and governance activities as needed.

Requirements

• Bachelor’s degree in a life science or related discipline.
• 8-10 years of experience in the pharmaceutical or biotech industry, with significant Regulatory Affairs experience.
• Small molecule drug development experience preferred.
• Global drug development experience preferred.
• CNS experience, in particular psychiatric or neurology indications preferred.
• Ability to manage competing priorities, influence and integrate within a team, manage timelines, and deliver on corporate and program goals.
• Strong interpersonal skills and alignment with Rapport’s values and company culture.
• Must demonstrate strong leadership and team-building skills, including experience with conflict resolution and real-time problem solving.
• Thorough understanding of the development phases within a fast-moving biopharmaceutical organization.
• 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.

Pay

The hiring range for this role is $200,000 to $225,000. 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 comprehensive benefits package.

Schedule

This role requires onsite presence in Boston, MA Monday-Wednesday every week.