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MapLight Therapeutics, Inc. · 5 days ago

Director, Regulatory Affairs

Burlington, MA

Full-time

Hybrid

Director/Executive

$185K/yr - $240K/yr

10+ years exp

MapLight Therapeutics is a clinical stage biotech company focusing on drug discovery for central nervous system disorders. The Director, Regulatory Affairs will lead global regulatory strategy for development-stage neuroscience programs, collaborating with cross-functional teams and ensuring regulatory alignment throughout the product development process.

BiopharmaBiotechnologyLife ScienceMedical

Responsibilities

Works with the Sr Director, Regulatory Affairs to develop and direct innovative and effective regulatory strategies in support of assigned MapLight portfolio projects

Provides advice on regulatory issues and actively collaborates with cross-functional team members, e.g., Clinical Pharmacology, Toxicology, Research, Clinical Development, Biostats, Data Management, Quality, CMC, Pharmacovigilance, Medical Writing, Commercial, publishing vendor, consultants, etc

May represent MapLight as point of contact with FDA and provides support for and coordination of regulatory meetings and briefing document development

Provide regulatory guidance on clinical development plans, CMC strategies, and nonclinical programs to ensure regulatory alignment

Lead or oversee the preparation and submission of regulatory documents, including INDs/CTAs, meeting packages, orphan drug applications, and other global regulatory filings

Interpret and communicate regulatory requirements and risks to internal teams and senior leadership

Monitor changes in the regulatory landscape relevant to neuroscience and provide strategic advice to adapt plans accordingly

Collaborate with external partners, consultants, and regulatory agencies to advance development programs

Qualification

Regulatory strategyRegulatory submissionsGlobal regulatory frameworksNeuroscience therapeuticsCross-functional collaborationCommunicationIndependent workFast-paced environment

Required

Minimum of 10 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with a focus on clinical-stage products

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

Preferred

Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field

Experience in regulatory strategy for neuroscience or CNS therapeutics

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

Company

MapLight Therapeutics, Inc.

Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).

Founded in 2018

Palo Alto, California, USA

51-200 employees