Strategic Regulatory Consultant

Strategic Regulatory Consultant (Part-Time, Neuropsychiatry & Oncology)

Warman O’Brien is supporting a biotech advancing innovative therapies in neuropsychiatry, neurodegeneration, and oncology. They are seeking an experienced Regulatory Leader to guide late-stage development and global regulatory strategy on a part-time basis.

The Role

• Lead regulatory strategy for Phase II–III neuropsychiatry programs.

• Support regulatory planning across oncology and rare neurodevelopmental assets.

• Design trial protocols, endpoints, and biomarker strategy.

• Drive IND/CTA submissions and briefing packages.

• Represent the company in FDA/EMA meetings (Pre-IND, EoP2, Pre-NDA).

About You

• Advanced degree (MD, PharmD, PhD) in psychiatry, neuroscience, or life sciences.

• Proven Phase II–III neuropsychiatry experience is essential (schizophrenia, depression, bipolar).

• Strong FDA/EMA engagement track record.

• Rare neurodevelopmental and/or oncology experience highly desirable.

• Strategic thinker with cross-functional leadership skills.

  Location: EU or US East Coast (remote/flexible)
  Hourly Rate: Competitive
  FTE: 0.2-0.4FTE