Director, Regulatory Strategy jobs in United States
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Rapport Therapeutics · 5 hours ago

Director, Regulatory Strategy

positionBoston, MA
timeFull-time
remoteHybrid
seniorityDirector/Executive
money$225K/yr - $250K/yr
date12+ years exp

Rapport Therapeutics is focused on developing precision neuromedicines to improve patients' lives. The Director of Regulatory Strategy will lead strategic regulatory initiatives for drug development programs, ensuring compliance with regulatory requirements and providing expertise to cross-functional teams.

BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine

Responsibilities

Create and implement innovative and effective regulatory strategies to support the development of Rapport global drug development programs
Provide regulatory expertise and advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical
Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc
Identify regulatory risks and mitigation plans
Serve as the regulatory lead on project teams
Ensure compliance with local and international submission requirements, manage CROs as applicable
Represents Rapport as the point of contact for regulatory health authorities, as assigned ensuring exemplary ethics and transparency within the company and with health authorities
Keeps current with global regulatory landscape and advises project teams on potential impact to programs
Provide mentorship and support to junior team members to foster their professional growth and development

Qualification

Regulatory strategyGlobal drug developmentPharmaceutical industry experienceNeurology experienceLeadership skillsCommunication skillsTeam buildingConflict resolutionProblem solvingInterpersonal skills

Required

Bachelors degree in a life science or related discipline
12+ years of experience in the pharmaceutical or biotech industry
Global drug development experience
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

Preferred

Experience in neurology and small molecules
Experience working with DAAP or Neurology FDA Divisions

Benefits

Unlimited PTO
A lifestyle spending account
Commuting reimbursement
And much more!

Company

Rapport Therapeutics

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Rapport Therapeutics is a clinical-stage biotechnology company that discovers and develops precision medicines for neurological disorders.
dateFounded in 2022
location
Boston, Massachusetts, USA
people-size11-50 employees
web-link
https://www.rapportrx.com

Funding

Current Stage
Public Company
Total Funding
$500M
Key Investors
Cormorant Asset ManagementThird Rock Ventures
2025-09-09Post Ipo Equity· $250M
2024-06-07IPO
2023-08-23Series B· $150M

Leadership Team

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Troy Ignelzi
Chief Financial Officer
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Cheryl Gault
Chief Operating Officer
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Recent News

thefly.com
Rapport Therapeutics plans to initiates its Phase 3 program for RAP-219
2026-01-08
GlobeNewswire
Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline
2026-01-07
GlobeNewswire
Rapport Therapeutics Announces New Data and Post Hoc Analysis Demonstrating the Magnitude and Consistency of RAP-219’s Clinical Response in Patients with Focal Onset Seizures
2025-12-05
Company data provided by crunchbase