Remote Senior 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

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.