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 Director, Regulatory Affairs will be a team player with a roll-up-the sleeves, can-do attitude and will report to the Vice President of Regulatory Affairs. A highly cross-functional role, this person will play a 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.
Primary Accountabilities, Duties, and Responsibilities
- Working closely with the VP of Regulatory Affairs to execute regulatory deliverables and implement regulatory strategy and with a high degree of independence in alignment with overall corporate goals and objectives
- Work proactively in a cross-functional organization to partner with various other functions to help execute an effective regulatory strategy in alignment with the overall clinical development plan and portfolio strategy
- 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 and execute as the RA lead, both in an operational and technical role.
- 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
- Prepare the team and lead negotiations with FDA, EMA, 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.
- Oversee and guide regulatory operations across multiple portfolio assets simultaneously, including budget and operational oversight of external vendors, etc.
- Experience with the drafting and submission of FDA specialty designation applications (ODD/RMAT/PRD) is preferred.
Essential Job Functions
- Job Scope – Strategy, planning, execution
- Travel – 20% (in a post COVID world)
Minimum Required Qualifications/Skills
- Bachelor’s degree in life sciences with 10+ years of industry experience, predominantly in Regulatory Affairs or consulting; Master’s degree in life science or related discipline, PharmD, MD, and/or PhD preferred in life sciences
- Successful submissions of multiple INDs, approval, and post-approval management of NDAs and/or BLAs in the US and other ICH regions
- Licenses or Certifications
- RAPS certification is preferred, but no required.
- 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
- IND/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.
- Interest in and/or experience in the following Therapeutic Area preferred: Neurology, Orphan Rare Diseases
- Able to work collaboratively
- Working Conditions
- Office (in a post COVID world)