Leal Therapeutics is seeking a highly driven (Associate) Director of Regulatory Affairs to join its team.

About Leal Therapeutics:

  • Biotechnology company developing novel, precision therapeutics for major diseases of the central nervous system (CNS) with critical unmet needs including ALS, Schizophrenia, and Alzheimer’s disease
  • Core operations in Worcester, MA and Philadelphia, PA
  • Fast-paced startup environment with broad exposure to multiple facets of biotechnology and drug development 
  • Emphasis on cross-functional collaboration within a collegial, learning-oriented environment
  • Continuous career development opportunities and support
  • Ability to have a large impact in a rapidly growing company

Key Responsibilities:

  • Develop and execute on regulatory strategy, submission, and compliance to bring CNS therapeutics to IND, CTA and beyond
  • Serve as primary Health Authority contact, including participating in meetings and assisting team in preparations
  • Lead and manage regulatory document prepatation, assembly, and submission, including for INDs and CTAs
  • Contribute to cross-functional decision-making and execution as regulatory lead
  • Provide regulatory guidance and advice for lead programs

Education, Experience, and Qualities Required:

  • Bachelor’s degree in a relevant discipline required; advanced degree preferred
  • A minimum for 5 years in biotechnology or pharmaceutical industry required
  • Experience in US and ex-US regulatory strategy and guidelines required
  • Experience in CNS disorders preferred
  • Experience with oligonucleotides or small molecules preferred
  • Strong organizational skillset with ability to manage multiple concurrent workstreams
  • Excellent verbal and written communication skills
  • Ability to work collaboratively in a fast-paced, dynamic environment
  • Passion for bringing new therapies to serve patients with unmet medical needs
 
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 status, disability, or any other legally protected status.
 

If interested, please contact Human Resources (hr@lealtx.com) with a brief statement of interest and resume.