SVP Global Regulatory Strategy — Biotech/Oncology

Sci.bio Recruiting; Boston (MA); On-site; USD 350,000 - 650,000; Full time

Job summary

Sci.bio Recruiting is assisting a clinical-stage biotechnology company in Boston in finding an accomplished regulatory leader. The role shapes path from early development through registration and requires steering clinical, CMC, and regulatory decisions toward a credible BLA and global registration.

The ideal candidate has led at least one BLA, with MAA experience preferred, and brings oncology or complex modality experience. Senior consultant, fractional or SVP-level options are considered.

Qualifications

• 15+ years in biopharma regulatory affairs.
• Led at least one BLA; MAA experience preferred.
• Background in oncology and complex modalities.
• FDA interactions and CMC experience required.

Responsibilities

• Define global regulatory strategy across lead program and emerging pipeline.
• Guide FDA and EMA interactions.
• Shape pivotal-development, endpoint and accelerated-pathway strategy.
• Advise on CMC comparability, potency, scale-up and approvability.
• Identify and mitigate downstream regulatory risk early.
• Build a fit-for-purpose regulatory capability as the company grows.

Skills

Regulatory leadership

BLA/MAA experience

FDA/EMA interactions

Oncology & complex modalities

CMC regulatory experience

VP/SVP leadership

Biopharma regulatory experience

Education

Advanced scientific or medical degree

Job description

Sci.bio Recruiting is assisting a clinical-stage biotechnology company in Boston in finding an accomplished regulatory leader. The role shapes path from early development through registration and requires steering clinical, CMC, and regulatory decisions toward a credible BLA and global registration.

The ideal candidate has led at least one BLA, with MAA experience preferred, and brings oncology or complex modality experience. Senior consultant, fractional or SVP-level options are considered.