Senior Director, Regulatory Strategy Program Lead

Rapport Therapeutics•Boston, MA

19h•$275,000 - $300,000•Hybrid

About The Position

Rapport Therapeutics is seeking a Senior Director, Regulatory Strategy Program Lead to lead regulatory strategy for RAP-219 and the company’s bipolar mania trials. The role will shape program development from early clinical trials through global filings, working with cross-functional teams to turn regulatory strategy into practical plans and decisions. The position combines broad strategic thinking with hands-on regulatory planning, document development, submission preparation, and problem-solving. The role works across Clinical, CMC, Nonclinical, and Clinical Pharmacology, and includes preparing for and leading health authority interactions, including FDA meetings. The Senior Director will oversee key submissions, identify and mitigate regulatory risks, communicate strategy and risks to colleagues and senior leadership, and help develop a regulatory team. The position partners with the Head of Regulatory Affairs on strategy, priorities, and key decisions. The ideal candidate is based in Boston, Massachusetts, with onsite presence Monday through Wednesday; remote candidates are also welcome. Rapport describes its work environment as bicoastal, with in-person collaboration at its Boston office Monday through Wednesday.

Requirements

Bachelor’s degree in a life science or related discipline.
12 or more years of experience in the pharmaceutical or biotech industry, with progressive responsibility in regulatory strategy.
Experience leading regulatory strategy for a development program.
Demonstrated experience navigating late-stage development and contributing to 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 judgment to know when to defer to others’ expertise.
Ability to influence cross-functional partners, manage competing priorities, and deliver program goals in a fast-moving biotech.
Strong interpersonal skills and alignment with Rapport’s values and culture.
Exceptional written and verbal communication skills.

Nice To Haves

Experience leading regulatory strategy for a neurology or psychiatry development program.
Experience with small molecules.

Responsibilities

Lead regulatory strategy for RAP-219, guiding development from early clinical trials through global filings.
Lead regulatory strategy for bipolar mania trials and partner with cross-functional teams on trial development, execution, and development decisions.
Translate strategy into hands-on regulatory planning, document development, submission preparation, and day-to-day problem-solving.
Shape program decisions across Clinical, CMC, Nonclinical, and Clinical Pharmacology.
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, ensuring high-quality content, global compliance, and coordination with external partners.
Grow and motivate a 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 and apply new insights to advance programs.