Director – Regulatory Affairs

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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vTv Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $80M Post-IPO Equity - vTv Therapeutics on 2025-09

Healthcare • Consulting • Logistics

vTv Therapeutics is a late-stage biopharmaceutical company developing oral, small-molecule drug candidates to treat diabetes and other chronic diseases. Its lead clinical program is cadisegliatin, a liver-selective glucokinase activator currently in Phase 3 as a potential first-in-class oral adjunctive therapy to insulin for people with type 1 diabetes. vTv focuses on improving glycemic control and reducing hypoglycemia risk through novel oral therapies and maintains active investor relations and clinical development programs.

📋 Description

• Develop, lead, and execute regulatory strategies through all phases of development from proof of concept through commercialization • Prepare for, lead, and document health authority meetings and liaise with health authorities throughout development • Provide regulatory guidance for internal and external project governance boards • Prepare, coordinate, lead, and author regulatory submissions, including clinical and marketing submissions, annual reports, investigator brochures, amendments, briefing books, responses to health authority information requests, and adverse event reporting • Act as the Regulatory Affairs expert on project teams, providing strategy and guidance through all development phases • Review nonclinical, clinical, and CMC documentation and contribute regulatory content • Collaborate with clinical study teams, project teams, commercial teams, CROs, consultants, and other external partners • Generate and refine product development strategy and advise on regulatory issues, solutions, and mitigation strategies • Monitor and assess the evolving US and global regulatory environment and communicate updates • Participate in external communication reviews with Commercial, Legal, and Medical/Clinical teams • Provide risk assessments of operational deliverables related to health authority guidance and organizational goals • Collaborate with Regulatory Operations to ensure quality and compliant submissions • Facilitate compliance with SOPs and regulatory work practices • Maintain professional working relationships and foster collaboration and idea sharing • Contribute to Regulatory Affairs budgets, forecasts, and inquiries

🎯 Requirements

• Bachelor's degree in a scientific discipline; higher degrees preferred • Minimum of 8+ years of experience in regulatory affairs in pharmaceutical/biotech • Experience with IND activity, global CTAs, DSURs, and agency briefing documents in 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, effectively negotiate, 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 capable of balancing strategic leadership with hands-on execution • Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders • Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies • Must be legally eligible for employment in the United States • Must answer whether sponsorship is required now or in the future

🏖️ Benefits

• Fully remote work arrangement

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