Neumora

Director, Regulatory Affairs

Neumora

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $221,675 - $244,434 per year

Job Level

Lead

About the role

  • 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.

Requirements

  • 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.
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)
  • Annual paid time off:
  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairsregulatory submissionsIND applicationsCTA applicationsdrug development processregulatory complianceclinical protocolsclinical study reportsstatistical analysis plansneuropsychiatric indications
Soft skills
analytical skillsproblem solvingpresentation skillscommunication skillsinterpersonal skillsleadershipself-startercollaborationstrategic guidanceinfluencing stakeholders
Certifications
B.S. degreeM.S. degree