MapLight Therapeutics, Inc.

Director, Regulatory Affairs

MapLight Therapeutics, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: California • Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $185,000 - $240,000 per year

Job Level

Lead

About the role

  • Lead global regulatory strategy for development-stage neuroscience programs.
  • Serve as the regulatory lead on cross-functional teams and be responsible for developing and implementing global regulatory strategies.
  • Work with the Sr Director, Regulatory Affairs to develop and direct innovative and effective regulatory strategies.
  • Provide advice on regulatory issues and actively collaborate with cross-functional team members.
  • Represent MapLight as a point of contact with FDA and provide support for regulatory meetings and briefing document development.
  • Provide regulatory guidance on clinical development plans, CMC strategies, and nonclinical programs.
  • Lead or oversee the preparation and submission of regulatory documents.
  • Monitor changes in the regulatory landscape relevant to neuroscience.

Requirements

  • Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field preferred.
  • Minimum of 10 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with a focus on clinical-stage products.
  • Experience in regulatory strategy for neuroscience or CNS therapeutics is highly preferred.
  • Demonstrated success leading regulatory submissions and interactions with global health authorities.
  • Strong understanding of global regulatory frameworks (e.g., FDA, EMA, ICH).
  • Proven ability to influence cross-functional teams and drive strategic outcomes.
  • Excellent written and verbal communication skills.
  • Ability to work independently and thrive in a fast-paced, evolving environment.
Benefits
  • annual bonus opportunity
  • medical
  • dental
  • vision
  • life and AD&D
  • short term and long term disability
  • 401(K) plan with match
  • stock options
  • flexible non-accrual paid time off
  • parental leave
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory strategyregulatory submissionsclinical development plansCMC strategiesnonclinical programsglobal regulatory frameworksFDAEMAICH
Soft Skills
influence cross-functional teamsdrive strategic outcomesexcellent written communicationexcellent verbal communicationwork independentlythrive in fast-paced environment
Certifications
PhDPharmDMDMS