At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.
The Director, Regulatory Operations will be a team player with a roll-up-the sleeves, can-do attitude and will report to the Senior Vice President, 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.
Accountabilities and Responsibilities
- Work closely with the SVP, Regulatory Affairs, and regulatory staff to execute deliverables and implement regulatory strategy with a high degree of independence in alignment with corporate goals and objectives
- Work proactively in a cross-functional organization to partner with various other departments to execute an effective regulatory strategy in alignment with the overall program development plan and portfolio strategy
- Provide regulatory oversight and guidance to project teams on regulatory compliance matters, health authorities and other competent authority requirements, provide regulatory perspective on clinical trial design to ensure that endpoints ultimately support a future product approval
- Serve as the primary regulatory agency contact and independently manage projects as the regulatory lead, both in an operational and technical role
- Lead the planning, preparation and delivery of submissions throughout product life cycles, 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 health authorities. This includes preparation of responses to questions and inquiries from the health authorities, overseeing the writing of meeting materials, leading 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 drafting and submitting health authorities specialty designation applications (ODD/RMAT/RPDD) is preferred
- Job Scope
- Operations, planning, execution of strategy
- Leadership Responsibility
- Education Bachelor’s degree in life sciences with 7+ years of industry experience, predominantly in Regulatory Affairs; Master’s degree in life science or related discipline, PharmD, MD, and/or PhD preferred.
- Experience Successful leadership of IND submissions, approval and post-approval management of NDAs/BLAs/MAAs required. Experience working with biologic product development is strongly preferred.
- Licenses or Certifications RAPS certification is preferred, but not required.
- Full functional knowledge of GLP, GCP and GMP regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of biopharmaceutical drug products in multiple ICH regions;
- Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills
- NDA/BLA and/or MAA 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