Senior Director, Regulatory Science

Job overview

The Senior Director, Regulatory Science role follows a hybrid schedule based in Back Bay, Boston, MA: three days in the office Monday through Wednesday and two remote days Thursday and Friday. Compensation is not specified. The role supports Newleos Therapeutics, a clinical-stage neuroscience company developing treatments across several indications. Reporting to the Chief Medical Officer, this leader shapes and executes global regulatory strategies across clinical programs. The role guides agency engagement, regulatory submissions, development pathways, and cross-functional alignment to support compliant progress through development stages.

What you'll do

• Lead global regulatory strategy for clinical assets across development phases
• serve as primary contact with regulatory agencies and prepare and lead key meetings
• oversee regulatory document preparation, submission, and maintenance
• advise on clinical development plans, regulatory pathways, risk mitigation, and data requirements
• partner with Clinical, CMC, Nonclinical, and Quality
• monitor regulatory intelligence and guidelines
• support regulatory aspects of business development, investor communications, and potential global filings.

What we're looking for

Skills & competencies

regulatory science

regulatory affairs

neuroscience

cns

neuropsychiatry

fda

ema

clinical development

hybrid

boston ma

newleos therapeutics

Work arrangement

• Weekend coverage required

Why this role

Hybrid work model with three office days and two remote days each week; focus on CNS and neuropsychiatry drug development.

About the employer

Newleos Therapeutics is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.