Director, Regulatory Affairs at page_title

2h ago

Director, Regulatory Affairs

Remote (US)

$220,000-$240,000 / year

full-timedirector Remotebiotechnology

Description

You will lead global regulatory strategy for development-stage neuroscience programs at MapLight Therapeutics, a clinical-stage biotech company focused on CNS drug discovery. You'll develop regulatory strategies from early development through approval, serve as the regulatory lead on cross-functional teams, and interface with FDA and other global health authorities.

Requirements

Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field preferred
Minimum 10 years of regulatory affairs experience in biotech/pharma with clinical-stage products
Experience in regulatory strategy for neuroscience or CNS therapeutics highly preferred
Demonstrated success leading regulatory submissions and interactions with global health authorities
Strong understanding of global regulatory frameworks (FDA, EMA, ICH)

Responsibilities

Develop and direct innovative regulatory strategies for assigned portfolio projects
Provide regulatory guidance on clinical development, CMC strategies, and nonclinical programs
Lead preparation and submission of regulatory documents (INDs, CTAs, meeting packages, orphan drug applications)
Interpret and communicate regulatory requirements and risks to internal teams and senior leadership
Monitor regulatory landscape changes and provide strategic advice

page_title

It’s an unprecedented time to be in neuroscience. Join us as we translate knowledge about brain circuitry into targeted treatments with the potential to improve the lives of those with difficult to treat brain disorders. MapLight boasts competitive traditional benefits such as 401K matching, a flexible vacation policy, weekly lunches, and team building events ranging from sailing excursions to bowling nights. But what truly sets us apart is our culture. At MapLight, you’ll be part of a cohesive and high-functioning team. Rigorous science, transparency, and integrity guide our decision making. MapLight employees are talented and driven but just as committed to inspiring, mentoring and supporting those around them. We each bring diverse backgrounds and skill sets but all share the ambitious vision to achieve transformative therapeutic breakthroughs. Come join our small but mighty team as we leave our mark on the world, and have fun in the process! Notice Regarding Employer Impersonation Job Scams: Recently, we have become aware of several instances of employer impersonation job scams that use our company’s name and logo. We want to emphasize that MapLight Therapeutics does not engage in any third-party recruitment nor use intermediaries for hiring purposes. Open positions at MapLight, when available,…

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