Remote Senior Director, Regulatory Affairs

vTv Therapeutics Inc.; United States; A distancia; USD 180.000 - 230.000; Jornada completa

Descripción de la vacante

vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. The lead asset, cadisegliatin, is studied as a potential adjunctive therapy to insulin for type 1 diabetes.

The Director/Sr Director of Regulatory Affairs will lead regulatory strategies across development and engage with US and ex-US health authorities. The role requires substantial regulatory affairs leadership, guiding projects through the regulatory lifecycle and

Formación

• 8+ years in regulatory affairs in pharmaceutical/biotech with IND activity and global CTAs.
• Experience with FDA and international regulations; interaction with health authorities.
• Proven ability to develop strategic regulatory plans and lead teams.
• Strong communication and negotiation skills for fast-paced biotech settings.

Responsabilidades

• Develop and execute regulatory strategies across all development phases.
• Lead health authority meetings and liaise with authorities throughout development.
• Provide regulatory guidance for governance boards and cross-functional teams.
• Prepare and coordinate regulatory submissions and responses with cross-functional teams.
• Collaborate with CROs, consultants, and internal teams to refine development strategy.
• Monitor US/global regulatory requirements and communicate updates.
• Ensure compliant submissions through Regulatory Operations.

Conocimientos

Regulatory leadership

FDA regulations

Strategic planning

Cross-functional collaboration

Risk assessment

Regulatory submissions

Educación

Bachelor's degree in a scientific discipline

Advanced degree preferred

Herramientas

Electronic submission templates

Review/submission technologies

Clinical disclosure portals

Descripción del empleo

vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. The lead asset, cadisegliatin, is studied as a potential adjunctive therapy to insulin for type 1 diabetes.

The Director/Sr Director of Regulatory Affairs will lead regulatory strategies across development and engage with US and ex-US health authorities. The role requires substantial regulatory affairs leadership, guiding projects through the regulatory lifecycle and