Director/Sr. Director, Regulatory Affairs

About vTv

Description

Key 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 (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as related to regulatory oversight and guidance.
• Collaborate with cross-functional teams (e.g. Clinical Study Teams, Project Teams, Commercial) and with external business partners such as CROs, consultants, etc. to generate and refine the product development strategy, advise team members of major regulatory issues and provide possible solutions and/or mitigation strategies.
• Maintain a knowledge of current US and global regulatory requirements to ensure compliance while monitoring and assessing the continued development of the regulatory environment; communicate regulatory updates to inform program strategies.
• Participate in the external communication reviews along with Commercial, Legal, Medical/Clinical team members in the development of applicable materials.
• Contribute as a functional Regulatory Affairs expert providing risk assessment of operational deliverables related to health authority guidance documents and organizational goals.
• Collaborate effectively with Regulatory Operations to ensure quality and content of compliant submissions.
• Facilitate the compliance to SOPs and work practices governing all phases of the regulatory process
• Maintain professional working relationships with colleagues, fostering collaboration, and idea sharing to promote highly interconnected corporate operating culture.
• Contribute to budgets, forecasts, and inquiries for Regulatory Affairs. 

Qualifications/Skills

• Bachelor’s 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 success/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.