Associate Director/Director, Regulatory Strategy

Rapport Therapeutics•Boston, MA

13h•$200,000 - $225,000•Hybrid

About The Position

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. This role involves creating and implementing innovative and effective regulatory strategies to support late-stage global drug development programs. The position requires providing regulatory expertise and advice to cross-functional team members, maintaining regulatory applications (INDs, CTAs, NDAs, etc.), identifying and mitigating regulatory risks, and serving as the regulatory lead on study teams. The role also includes ensuring compliance with submission requirements, managing regulatory CROs, representing the company in interactions with regulatory health authorities (FDA, EMA, etc.), and monitoring the evolving global regulatory landscape.

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
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

Nice To Haves

Experience small molecule drug development preferred
Global drug development experience preferred
CNS experience, in particular psychiatric or neurology indications preferred

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 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.