Head of Regulatory Science

Job Description

Job Description

Salary : The Company :

Newleos Therapeutics is a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development. Newleos clinical-stagepipelinewas in-licensed from Roche and includes multiple oral small molecules targeting novel mechanisms across a broad range of indications, including generalized anxiety, social anxiety, substance use disorders, and cognitive impairment.

For more information on the Company, please visit https : / / www.newleos.com

Position Overview :

The Vice President of Regulatory Science will be responsible for shaping and executing global regulatory strategies across our clinical programs. Reporting to the Chief Medical Officer (CMO), the VP will play a critical leadership role in interactions with regulatory authorities, including the FDA and EMA, and will ensure regulatory excellence across all development stages.

This role requires deep expertise in neuropsychiatry drug development, early-to-late phase regulatory engagement, and a proactive, hands-on approach in a fast-paced, startup environment.

This role is based in Back Bay, Boston, and follows a hybrid work modelthree days per week (Monday, Tuesday, Wednesday) in the office and two days (Thursday and Friday) remote.

Responsibilities :

• Lead global regulatory strategy for all clinical assets across development phases, ensuring alignment with corporate goals and compliance with FDA and EMA requirements.
• Serve as the primary point of contact with regulatory agencies, including preparation and leadership of key meetings (e.g., pre-IND, End-of-Phase 2, Scientific Advice).
• Oversee preparation, submission, and maintenance of regulatory documents (e.g., INDs, CTAs, briefing books, meeting packages, Orphan Drug applications, Fast Track / Breakthrough requests).
• Provide strategic guidance on clinical development plans, regulatory pathways, risk mitigation, and data requirements.
• Partner cross-functionally with Clinical, CMC, Nonclinical, and Quality to ensure regulatory alignment and timely submissions.
• Monitor regulatory intelligence and evolving guidelines in neuropsychiatry and CNS.
• Support regulatory aspects of business development, investor communications, and potential global filings.

Qualifications :

Newleos Therapeutics is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.