Director/Sr. Director, Regulatory Affairs

vTv Therapeutics LLC; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Fully Remote

Job summary

vTv Therapeutics LLC is seeking a Director/Sr Director of Regulatory Affairs to drive regulatory strategy across its lead asset and pipeline. You will guide interactions with US and international health authorities, lead teams, and ensure compliant submissions through cross-functional collaboration in a fast-paced biopharma environment.

The role emphasizes strategic leadership, consistency with regulatory timelines, and proactive risk management while enabling growth across indications.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degrees preferred.
• 8+ years regulatory affairs experience in pharma/biotech.
• Experience with FDA and global regulatory requirements.
• Experience leading teams and interacting with health authorities.
• Proven success in major submissions/approvals.
• Familiarity with submission technologies and clinical disclosure portals.
• Detail oriented with strong communication and leadership.
• Able to balance strategic leadership with hands-on execution.

Responsibilities

• Develop lead regulatory strategies across all phases of development.
• Prepare for and lead health authority meetings and liaise with authorities.
• Provide regulatory guidance for internal governance boards.
• Prepare, coordinate, and author all regulatory submissions with cross-functional teams.
• Act as regulatory affairs expert on project teams with strategy guidance.
• Review nonclinical, clinical and CMC documentation for regulatory oversight.
• Collaborate with cross-functional teams and external partners to refine strategy.
• Maintain knowledge of US and global regulatory requirements and communicate updates.
• Contribute to budgets, forecasts and inquiries for Regulatory Affairs.

Skills

Regulatory strategy leadership

FDA knowledge

Global regulatory knowledge

Cross-functional leadership

Regulatory submissions

Effective communication

Negotiation & risk management

Education

Bachelor's degree in a scientific discipline

Advanced degree in life sciences

Tools

eCTD submissions portal

Job description

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*