Neumora

Compliance

• Independently serve as the regulatory representative on cross-functional teams.
• Communicate regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed.
• Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory results and ensure strategic integration of regulatory considerations into program plans.
• Independently lead the central messaging, preparation, and submission of high-quality, regulatory-complaint regulatory dossiers.
• Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teams.
• Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements.
• Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines.
• Ensure accuracy and consistency of regulatory submissions and correspondence. Handle vendor/consultant roles, where applicable.
• Serve as the regulatory point of contact for interactions with FDA and other global health authorities.
• Critically review nonclinical and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provide regulatory strategic guidance on documents and submission plans to align with study and company objectives.
• Interact directly with regulatory agencies; manage agency interactions.
• Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations.
• May assist with due diligence to support business development opportunities.
• Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.

Director, Regulatory Affairs

Vice President

• Leads the program core team, responsible for creating and developing the program strategy and operational plan including realistic timelines, budget and resource planning, risk assessment and contingency planning
• Accountable for the quality of the team’s output, consistently drives to generate the highest quality and highest integrity data that enables clear decision-making at the company level
• Drives decision-making and issues resolution within the team and through the governance process
• Ensures cross-functional alignment and organizational support for the execution of the operational plan by facilitating internal and external stakeholder meetings
• Drives the team to out-of-box thinking and creative issue resolution
• Challenges assumptions, timelines and expenses at program level, pressure tests plans, creates alternative scenarios to enable strategic and operational agility
• Manages prioritization of program team activities to enhance program value
• Acts as spokesperson for the program and represents program internally and externally
• In partnership with the team Project Manager, responsible for comprehensiveness and quality of program information in the internal systems and databases. Responsible for communication to Senior Management
• Expected to identify bottlenecks, surface issues, and proactively drive for their resolution, and to lead contingency planning efforts
• Leads ad-hoc cross-functional task forces, as needed, aiming at issue resolution or organizational efficiency
• Manages project variance and root cause analysis, develops risk mitigation/ issue management plans with the objective to meet the financial targets

Director, Regulatory Affairs

Vice President, Program Team Lead – Biotech/Pharma