Vice President of Regulatory Affairs

Location: Remote

Leal Therapeutics is seeking a Vice President of Regulatory Affairs. This role will report to the Chief Medical Officer.

About Leal Therapeutics:

• Clinical-stage biotechnology company developing novel, neuro-metabolic therapeutics for diseases of the central nervous system (CNS) with critical unmet needs including Schizophrenia and ALS.
• Core operations in Worcester, MA and Newton, MA
• Fast-paced startup environment with broad exposure across multiple facets of biotechnology and drug development
• Emphasis on cross-functional collaboration within a collegial, learning-oriented environment
• Ability to have a large impact in a rapidly progressing company

Key Responsibilities:

Regulatory Strategy

• Develop and own the global regulatory strategy for two CNS/neurology clinical programs from IND through NDA/BLA, in alignment with overall program objectives
• Serve as the primary FDA contact and relationship lead; plan, prepare, and lead all FDA interactions including Pre-IND, Type B, and Type C meetings
• Provide regulatory input into clinical trial design, protocol development, and CMC strategy to ensure alignment with agency expectations
• Assess and communicate regulatory risks and mitigation strategies to the CMO, CEO, and Board as needed
• Evaluate opportunities for expedited programs including Fast Track, Breakthrough Therapy, and Accelerated Approval designations

Submissions & Operations

• Direct the preparation and submission of INDs, IND amendments, annual reports, and safety reports
• Lead authoring and review of regulatory documents including briefing documents, clinical sections, and agency correspondence
• Oversee labeling strategy and lead label negotiations with FDA
• Establish and maintain regulatory submission infrastructure, including systems, templates, and vendor relationships as needed
• Ensure regulatory compliance across all development activities in accordance with applicable FDA regulations and ICH guidelines

Cross-Functional Leadership

• Partner closely with Clinical Development, CMC, Pharmacovigilance, and Legal to integrate regulatory strategy across functions
• Represent Regulatory Affairs on program teams and provide strategic guidance at the executive level
• Build and mentor a small regulatory affairs team; establish processes and culture that will scale with the organization
• Support business development activities including due diligence for potential in-licensing or partnership opportunities

Education, Experience, and Qualities Required:

Required

• Advanced degree in a relevant scientific discipline (PharmD, PhD, MD, or MS); PharmD strongly preferred
• 12+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry
• Deep expertise in FDA regulations and CNS/neurology drug development, including IND management and FDA meeting strategy
• Demonstrated experience leading FDA interactions and negotiating with agency reviewers
• Track record of filing and managing INDs across multiple programs
• Prior experience in a small biotech or startup environment, or demonstrated ability to operate with limited resources and high autonomy
• Excellent written and verbal communication skills; able to distill complex regulatory concepts for executive and Board audiences

Preferred

• Prior FDA reviewer or senior FDA staff experience (e.g., Division of Neurology Products or related)
• Experience leading or contributing to an NDA or BLA submission and approval
• Familiarity with expedited development programs (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review)
• Experience with pediatric regulatory strategy including Written Requests and Pediatric Study Plans
• Familiarity with global regulatory strategy (EMA, Health Canada) as programs advance
• Experience implementing regulatory information management systems (e.g., Veeva RIM)

Leal is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national orientation, veteran, or disability status.

If interested, please contact humanresources@lealtx.com with a brief statement of interest and resume.