Director, Regulatory Affairs

Role Summary

Director, Regulatory Affairs to lead regulatory strategies for assigned programs, serving as the regulatory representative on cross-functional teams and guiding development plans from early through late-stage development. The role involves independence in messaging, dossier preparation and submission, and interaction with global health authorities, including the FDA.

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.

Qualifications

• 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.

Education

• B.S./M.S. degree in a scientific discipline or related field.