Associate Director/Director, Regulatory Strategy

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.

• 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 include the coordinate meeting requests, briefing documents, and responses to regulatory questions.
• Monitor and interpret evolving global regulatory landscape and advise project teams on potential impact to programs
• Support portfolio planning and governance activities as needed.

• 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
• Experience small molecule drug development 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

• 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.