This clinical-stage gene therapy company is developing life-changing treatments for severe neurological diseases. They are in search of a Vice President or SVP of Global Regulatory Affairs to develop and implement global regulatory strategies while also building out the regulatory function for the company. Reporting to the Head of R&D and Chief Medical Officer, you will develop regulatory processes and systems to support the growing and evolving needs of the business. You will interface directly with Senior Management members and the Board of Directors, while also leading global health authority interactions. Now is an exciting time to join this growing organization and help to get innovative gene therapy programs approved!
- Provide strategic regulatory leadership to all project teams across all stages of clinical development for neurological disease gene therapy programs.
- Design and execute an effective global regulatory strategy in alignment with the overall development plan and corporate goals.
- Lead and supervise submissions throughout the product’s life cycle, including INDs, and various expedited designation requests including breakthrough, orphan drug, fast track and rare pediatric disease where appropriate.
- Lead the planning, strategy, content and execution of BLA filing, approval and post-approval commitments including label extension and lifecycle management
- Lead teams in a cross-functional organization to partner with various R&D areas across research, clinical, quality, regulatory, program management and CMC areas
- Work closely with other disciplines to prepare and execute global development programs addressing the needs of each partner.
- Prepare the team and lead negotiations with FDA and other health agencies.
- Provide regulatory due diligence as required.
- Hire, supervise, and mentor direct reports on the regulatory team.
- Establish regulatory processes and SOPs to support the needs of the business.
- A minimum of a Bachelor’s degree is required. An advanced degree (i.e. PharmD, PhD. MD degree) is preferred.
- A minimum of 15 years of experience working in Global Regulatory Affairs with strong experience with biologics.
- Gene therapy and pediatrics experience a plus.
- Experience in a small biotech company environment is preferred.
- Thorough knowledge of the drug development process including expedited pathways and orphan drug designations, INDs, CTAs BLAs and MAAs required.
- Experience in interfacing with FDA, EMA, PMDA and other Health authorities.
- Therapeutic area expertise in neuroscience and/or rare diseases is desirable.
- A track record of biologic product development with successful product approvals in the US, EU, and/or Asia.
- Must have successfully developed innovative pathways to approval for novel biologic programs.
- Demonstrated strategic thinking and implementation in overall drug development.
- Must have strong experience in building and leading regulatory teams and establishing SOPs.