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Sr. Director, Regulatory Science at Newleos - ApplyBlast

Sr. Director, Regulatory Science

Newleos

2 months ago

Boston, Massachusetts, United States

Hybrid

Full Time

Director

0 applicants

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About this role

The Sr. Director, Regulatory Science at Newleos Therapeutics will shape and execute global regulatory strategies for clinical programs, serving as the primary liaison with FDA and EMA. Reporting to the CMO, this senior leader will oversee regulatory submissions, guide clinical development pathways, and collaborate cross‑functionally to ensure compliance and strategic alignment.

Responsibilities

Lead global regulatory strategy for clinical assets
Serve as primary liaison with FDA and EMA
Oversee preparation and submission of regulatory documents

Skills

Qualifications

PhDPharmDMDMSc

About Newleos

newleos.com

Newleos Therapeutics is a clinical-stage biotechnology company co-founded by Longwood Fund, focused on developing innovative treatments for mental health conditions. The company's pipeline, licensed from Roche, consists of oral small molecules targeting GABAA-γ1, V1a, TAAR1, and GABAA-α5 with first- or best-in-class potential. Its lead programs aim to treat general anxiety, social anxiety, substance use disorders, and cognitive impairment with improved outcomes over the current standard of care.