Director/Sr. Director, Regulatory Affairs

vTv Therapeutics•High Point, NC

7d•Remote

About The Position

vTv Therapeutics is a clinical-stage biopharmaceutical company developing oral, small-molecule drug candidates. Its pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for type 1 diabetes, with development partners pursuing additional indications including type 2 diabetes and other chronic conditions. The Director/Sr. Director of Regulatory Affairs reports to the VP/Head of Regulatory Affairs and supports development of the lead asset and the broader pipeline across therapeutic indications. This role leads regulatory strategy throughout all phases of development, engages with US and ex-US regulatory health authorities, and collaborates cross-functionally to advance organizational goals. The position calls for substantial regulatory experience and leadership to guide programs through the regulatory lifecycle. The role is fully remote.

Requirements

Bachelor’s degree in a scientific discipline; higher degrees preferred.
At least 8 years of regulatory affairs experience in pharmaceutical or biotechnology, including experience with IND activity, global CTAs, DSURs, and agency briefing documents in the US and ex-US.
Experience interacting with health authorities and leading teams.
Strong working knowledge of FDA and/or ex-US regulations.
Demonstrated ability to develop strategic regulatory plans, facilitate team decisions, negotiate effectively, and execute strategies in a fast-paced clinical-stage biotech environment.
Proven success or major involvement in major submissions and/or approvals.
Experience with electronic templates, review and submission technologies, and clinical disclosure portals.
Detail-oriented, proactive, and able to balance strategic leadership with hands-on execution.
Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders.
Ability to identify risks, solve complex regulatory challenges, and implement proactive mitigation strategies.

Nice To Haves

Higher degree in a scientific discipline.

Responsibilities

Develop, lead, and execute regulatory strategies for vTv programs from proof of concept through commercialization.
Prepare for, lead, and document health authority meetings, and liaise with health authorities throughout development.
Provide regulatory guidance to internal and external project governance boards.
Prepare, coordinate, lead, and author regulatory submissions, including clinical and marketing submissions, annual reports, investigator brochures, amendments, meeting briefing books, responses to health authority information requests, and adverse event reports.
Serve as the Regulatory Affairs expert on project teams, providing regulatory strategy and guidance through all phases of development.
Review and contribute regulatory oversight and guidance to nonclinical, clinical, and CMC documentation, including study reports, protocols, investigator brochures, and CMC information or data.
Collaborate with cross-functional teams and external business partners, including CROs and consultants, to develop and refine product development strategies, communicate major regulatory issues, and recommend solutions or mitigation strategies.
Maintain knowledge of current US and global regulatory requirements, monitor changes to the regulatory environment, and communicate updates to inform program strategies.
Participate in reviews of external communications with Commercial, Legal, and Medical/Clinical team members.
Provide regulatory risk assessments of operational deliverables related to health authority guidance and organizational goals.
Work with Regulatory Operations to ensure the quality and content of compliant submissions.
Facilitate compliance with SOPs and work practices governing the regulatory process.
Maintain professional working relationships and foster collaboration and idea sharing across the organization.
Contribute to Regulatory Affairs budgets, forecasts, and inquiries.