Director/Sr. Director, Regulatory Affairs

vTv Therapeutics Inc.; High Point (NC); A distancia; USD 180.000 - 230.000; Jornada completa

Descripción de la vacante

vTv Therapeutics Inc. seeks a Director/Sr Director of Regulatory Affairs to drive regulatory strategy for lead asset and pipeline across trials, with ongoing engagement with US and international health authorities. You will shape submissions, governance, and risk mitigation to reach regulatory milestones.

You will lead teams across Clinical, CMC, Legal and Commercial, align with evolving FDA/global rules, and ensure timely, compliant decision-making in a dynamic biotech setting. Fully remote.

Formación

• 8+ years in regulatory affairs in pharma/biotech.
• Experience with IND activity, global CTAs, DSURs, and health authority briefs.
• Proven ability to lead teams and develop regulatory strategies in biotech.
• Strong communication with authorities, leadership, and cross-functional partners.

Responsabilidades

• Develop regulatory strategies through all development phases.
• Lead health authority meetings and liaise with agencies globally.
• Provide regulatory guidance for governance boards and teams.
• Coordinate regulatory submissions and manage cross-functional review.
• Maintain current knowledge of US/global regulatory requirements.

Conocimientos

Regulatory leadership

FDA knowledge

Strategic planning

Team leadership

Educación

Bachelor's degree in science

Advanced degree preferred

Herramientas

eCTD/submission tools

Descripción del empleo

About vTv

vTv Therapeutics is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications, including type 2 diabetes and other chronic conditions.

Description

The Director/Sr Director of Regulatory Affairs, reporting to the VP/Head of Regulatory Affairs, will support the development our lead asset as well as our pipeline across therapeutic indications. We are seeking an innovative and agile candidate who will be responsible for regulatory strategy across all phases of development including active engagement with US and ex-US regulatory health authorities and cross functional collaboration to achieve the organizational goals. The ideal candidate brings substantial Regulatory Affairs experience and leadership, to navigate the vTv program(s) through the regulatory lifecycle.

Key Responsibilities

• Develop lead and execute against regulatory strategies through all phases of development of vTv programs from proof of concept through commercialization.
• Prepare for, lead and document health authority meetings and continue to liaise with health authorities throughout development.
• Provide regulatory guidance for internal and external project governance boards for vTv programs.
• Prepare, coordinate, lead and author, all aspects of regulatory submissions (e.g., clinical/marketing submissions, annual reports, investigator brochures, amendments, briefing book for health authority meetings, responses to health authority information requests, adverse event reporting) with internal and external cross-functional teams.
• Act as the functional Regulatory Affairs expert on project teams, providing regulatory strategy and guidance through all phases of development.
• Review nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as related to regulatory oversight and guidance.
• Collaborate with cross-functional teams (e.g. Clinical Study Teams, Project Teams, Commercial) and with external business partners such as CROs, consultants, etc. to generate and refine the product development strategy, advise team members of major regulatory issues and provide possible solutions and/or mitigation strategies.
• Maintain a knowledge of current US and global regulatory requirements to ensure compliance while monitoring and assessing the continued development of the regulatory environment; communicate regulatory updates to inform program strategies.
• Participate in the external communication reviews along with Commercial, Legal, Medical/Clinical team members in the development of applicable materials.
• Contribute as a functional Regulatory Affairs expert providing risk assessment of operational deliverables related to health authority guidance documents and organizational goals.
• Collaborate effectively with Regulatory Operations to ensure quality and content of compliant submissions.
• Facilitate the compliance to SOPs and work practices governing all phases of the regulatory process
• Maintain professional working relationships with colleagues, fostering collaboration, and idea sharing to promote highly interconnected corporate operating culture.
• Contribute to budgets, forecasts, and inquiries for Regulatory Affairs.

Qualifications/Skills

• Bachelor's degree in a scientific discipline; higher degrees preferred.
• Minimum of 8+ years of experience in regulatory affairs in pharmaceutical/biotech, (e.g., IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US).
• Experience interacting with health authorities, leading teams, and strong working knowledge of FDA and/or ex-US regulations.
• Demonstrated ability to develop strategic regulatory plans, facilitate team decisions, effectively negotiate, and execute strategies in a fast-paced clinical-stage biotech environment.
• Proven success/major involvement in major submissions and/or approvals.
• Experience with electronic templates, review and submission technologies, and clinical disclosure portals.
• Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution.
• Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders.
• Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies.

*Fully Remote*