Global Regulatory Affairs Director - Fully Remote

vTv Therapeutics Inc.; High Point (NC); Remote; USD 180,000 - 230,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory leadership

FDA knowledge

Strategic planning

Team leadership

Education

Bachelor's degree in science

Advanced degree preferred

Tools

eCTD/submission tools

Job description

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.