Neurogene exists to provide medicines to cure or substantially improve the lives of families and people living with neurologic impairment. The day to day difficulty of caring for someone with a devastating neurologic disorder is a heavy burden for families, and we imagine a world where families no longer have to hear the message that their rare disease has no treatment. As an employee of Neurogene, you will be helping to make this dream a reality, and part of a culture of people in a start-up environment on a mission to make the world a better place!
The Senior Vice President, Regulatory Affairs will be a highly strategic leader and team player in a small company environment. A highly cross-functional and highly visible role, this person will play the lead role in the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre-clinical stage to accelerated clinical development. This leader will oversee the day-to-day regulatory activities, be the regulatory representative for Neurogene, develop and plan regulatory submission strategies, and conduct regulatory intelligence activities. The SVP, Regulatory Affairs, will build and lead his/her own team, work closely with members of the R&D and Tech Ops teams, interact with regulatory agencies and ensure the timely preparation of scientifically valid submissions.
Ideally, the candidate will be located in/relocate to the New York City area.
- Define strategy and required content of scientifically sound, accurate and complete preclinical and clinical submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.)
- Provide management and leadership of the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals
- Serve as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes
- Create regulatory strategy and implement regulatory objectives to meet corporate goals and objectives
- Work proactively in a cross-functional organization to partner with various other functions to help plan and execute an effective regulatory strategy in alignment with the overall clinical development plan and manufacturing plan
- Work effectively with key external collaborators to foster a collaborative relationship with Neurogene
- Provide regulatory oversight and guidance to project teams on regulatory compliance matters, FDA and other competent authority requirements, provide regulatory perspective on clinical trial design to ensure ultimately that endpoints support a future regulatory approval
- Independently manage projects, functioning as the single, accountable, point of contact on those projects
- Lead the planning, preparation and delivery of submissions throughout the product’s life cycle, including briefing documents, INDs, CTAs and annual reports.
- Review critical regulatory communications and evaluate conformance with the regulatory requirements, clarity, and completeness
- Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
- Independently interact with regulatory agencies and in some cases, act as the primary contact with those agencies
- Prepare the cross-functional team and lead negotiations with FDA and other health agencies. This includes preparing responses to questions and inquiries from FDA and other health authorities, overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.
- Supervise, mentor, and train direct reports who will be managing other programs
- Manage key vendors in support of all regulatory filings
- 15+ years of industry experience, predominantly in Regulatory Affairs;
- Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision
- Proven experience in preparing strategies for and submitting applications (INDs, NDAs, MAAs) in gene therapy or rare disease programs
- B.S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired. RAC accreditation is desirable
- Experience building, leading, growing, and scaling a Regulatory Affairs department, including leading people
- Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple ICH regions;
- Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills
- NDA and/or BLA filing experience preferred
- Strong influencing and negotiation skills combined with excellent oral and written communications skills
- Excellent organizational and analytical skills. Detail-oriented and a great ability to support multiple projects in a timeline-driven environment.