|Title:||Vice President, Regulatory Affairs|
Vice President, Regulatory Affairs
Reporting to the Chief Medical Officer (CMO), the Vice President of Regulatory Affairs will be responsible for developing and leading all regulatory strategies and activities for VenatoRx, including all regulatory submissions. This includes ensuring that all VenatoRx’s regulatory goals are met, and in compliance with all current industry standards globally. This role will manage internal Regulatory staff, oversee third party Regulatory service providers, and will be a key member of the development leadership team.
- Contribute to the development and implementation of pre-clinical, clinical, CMC, regulatory strategy for projects in all stages of development (pre-IND through NDA)
- Works cross-functionally with internal departments, including clinical, manufacturing, and third parties on Regulatory Affairs related issues.
- Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities.
- Defines strategies for, coordinate the execution of, and ensure the proper archival of regulatory submissions including clinical trial applications; Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Approvals (MAAs)
- Interpret FDA (and other regulatory body) communications, expectations and decisions to internal and external stakeholders (including CRO’s, CMO’s, consultants and contractors), developing and implementing successful issue resolution strategies.
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, and fast track applications applications.
- Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
- Contribute to the creation of the combination product strategy and manage the development, monitoring and delivery of integrated project plans throughout the lifecycle of development of combination product development,
- Manage the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
- Identify and assess regulatory risks projects or programs.
- Present operational plans, scientific data and strategy to internal and external audiences, including regulators, key opinion leaders, partners, and executives.
- Advise senior management of the impact the changing regulatory environment can/will have on VenatoRx’s business and projects.
- Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials.
- Responsible for cost-effective management of Regulatory Affairs department budget.
- Responsible for departmental resources, including recruitment, deployment, professional development and management of regulatory staff.
- Maintain, create relevant SOPs, Work Instructions and other necessary guidance.
- PhD with focus in Pharmaceutical Sciences or a technical field preferred. Will consider minimum BS or a MS degree holders:
- 20+(BS), 18+(MS), 14+(PhD) years of relevant and current work experience in the fields of Regulatory Affairs, Product Development, and/or Clinical Operations.
- 5+ years of demonstrated success in regulatory team leadership role and proven management by influence.
- Direct experience with FDA and international agencies required.
- Knowledge of regulations and regulatory process in all global markets.
- Solid understanding of dossier requirements New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA).
- Proven excellence in operational strategy.
- Ability to interpret, communicate, and present regulatory information in a clear and concise manner.
- Demonstrated ability to proactively and effectively influence peers and external colleagues across all levels of management.
- Proven negotiation skills.
- Self-starter, independent and a practical thinker
- Strong written and oral communication skills.