Director/Sr. Director, Regulatory Affairs

vTv Therapeutics • High Point, GA

1d • Remote

About The Position

The Director/Sr. Director of Regulatory Affairs reports to the VP/Head of Regulatory Affairs and supports development of vTv Therapeutics’ lead asset and pipeline across therapeutic indications. This role develops and executes regulatory strategy across all phases of development, engages with U.S. and ex-U.S. health authorities, and collaborates across functions to advance organizational goals. The position calls for substantial Regulatory Affairs experience and leadership to guide programs through the regulatory lifecycle.

The role provides regulatory expertise and guidance to project teams and governance boards; prepares, coordinates, leads, and authors regulatory submissions; reviews nonclinical, clinical, and CMC documentation; and works with internal teams and external partners to shape product development strategies. It also monitors regulatory requirements and changes, supports compliant submissions and operating practices, contributes to risk assessments and budgets, and participates in reviews of external communications.

Requirements

• Bachelor’s degree in a scientific discipline.
• At least 8 years of regulatory affairs experience in pharmaceutical or biotechnology settings, including experience with IND activity, global CTAs, DSURs, and agency briefing documents in the U.S. and ex-U.S.
• Experience interacting with health authorities and leading teams.
• Strong working knowledge of FDA and/or ex-U.S. 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 preferred.

Responsibilities

• Develop, lead, and execute regulatory strategies for vTv programs through all development phases, 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 and related materials, including clinical and marketing submissions, annual reports, investigator brochures, amendments, briefing books, responses to health authority information requests, and adverse event reporting.
• Serve as the Regulatory Affairs expert on project teams, providing regulatory strategy and guidance across development phases.
• Review nonclinical, clinical, and CMC documentation and contribute content related to regulatory oversight and guidance.
• 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 identify solutions or mitigation strategies.
• Maintain knowledge of current U.S. and global regulatory requirements, monitor changes in 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 support 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.
• Contribute to Regulatory Affairs budgets, forecasts, and inquiries.

What This Job Offers

• Job Type: Full-time
• Career Level: Director