Neumora · 1 day ago
Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$222K/yr - $244K/yr
10+ years expNeumora is a clinical-stage biopharmaceutical company focused on innovative treatments for brain diseases. They are seeking a highly motivated Director of Regulatory Affairs to lead regulatory strategies and oversee development plans for their programs, ensuring compliance with regulatory guidelines and effective communication with cross-functional teams.
BiotechnologyHealth CareMedicalNeuroscience
Responsibilities
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
Qualification
Required
B.S./M.S. degree in a scientific discipline or related field
Minimum of 10 years of Pharmaceutical Regulatory Affairs experience; experience in neuropsychiatric indications preferred
Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required
Experience supporting development stage programs (Phase 1-3)
Experience with IND/CTA and license applications
Experience with management of commercial product(s) highly desirable
Ability to work in a hybrid environment and with distributed teams; startup/small company experience preferred
Self-starter who can independently lead assigned projects
Experience in central nervous system disease research a plus
Strong analytical skills, problem solving ability, and presentation skills
Excellent communication and interpersonal skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds
Preferred
Experience in neuropsychiatric indications preferred
Ability to work in a hybrid environment and with distributed teams; startup/small company experience preferred
Experience in central nervous system disease research a plus
Benefits
Medical, dental, vision, and life insurance
401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
Company Equity (New Hire Awards, Annual Awards, ESPP)
Accrued Vacation Days: 15 days per year
Sick Days: 10 days per year
Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
Discretionary year-end bonus
Company
Neumora
Brain diseases collectively represent one of the largest areas of unmet medical need, affecting upwards of 1.5 billion patients globally.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$614.63MKey Investors
Parkinson's UKMubadala Capital VenturesARCH Venture Partners
2024-04-25Grant· $2.63M
2023-09-15IPO
2022-10-11Series B· $112M
Leadership Team
Carol Suh
Co-Founder and Chief Strategy Officer
Jason G. Duncan
Chief Legal and Administrative Officer
Recent News
Clinical Trials Arena
2026-01-06
2026-01-05
Company data provided by crunchbase