Director/Sr. Director Regulatory Affairs

Role Summary

The Director/Sr Director of Regulatory Affairs leads regulatory strategy across all development phases for vTv’s lead asset and the pipeline, engaging with US and international health authorities and collaborating across functions to achieve organizational goals. This role requires substantial Regulatory Affairs leadership to navigate programs through the regulatory lifecycle.

Responsibilities

• Develop lead and execute against regulatory strategies through all phases of development of vTv programs from proof of concept through commercialization.
• Prepare for, lead and document health authority meetings and continue to liaise with health authorities throughout development.
• Provide regulatory guidance for internal and external project governance boards for vTv programs.
• Prepare, coordinate, lead and author all aspects of regulatory submissions (e.g., clinical/marketing submissions, annual reports, investigator brochures, amendments, briefing book for health authority meetings, responses to health authority information requests, adverse event reporting) with internal and external cross-functional teams.
• Act as the functional Regulatory Affairs expert on project teams, providing regulatory strategy and guidance through all phases of development.
• Review nonclinical, clinical and CMC documentation and contribute to content as related to regulatory oversight and guidance.
• Collaborate with cross-functional teams and external partners to generate and refine the product development strategy, advising on major regulatory issues and providing mitigation strategies.
• Maintain knowledge of current US and global regulatory requirements to ensure compliance and inform program strategies.
• Participate in external communication reviews with Commercial, Legal, Medical/Clinical teams in the development of applicable materials.
• Provide risk assessment of operational deliverables related to health authority guidance documents and organizational goals.
• Collaborate with Regulatory Operations to ensure quality and content of compliant submissions.
• Facilitate compliance with SOPs and work practices governing all phases of the regulatory process.
• Maintain professional relationships to promote collaboration and an interconnected operating culture.
• Contribute to budgets, forecasts, and inquiries for Regulatory Affairs.

Qualifications

• Bachelor‚Äôs degree in a scientific discipline; higher degrees preferred.
• Minimum of 8+ years of experience in regulatory affairs in pharmaceutical/biotech (e.g., IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US).
• Experience interacting with health authorities, leading teams, and 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 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.

Education

Additional Requirements

• This is a Remote (work from home) position.