Senior Vice President of Regulatory Sciences

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

A clinical-stage biotechnology company developing a differentiated programmable mRNA platform is seeking an accomplished regulatory leader to help shape its path from early clinical development through registration.

This is a high-impact opportunity to work directly with the executive team at a critical inflection point. The mandate is not simply to manage submissions, but to work backward from approval and ensure that clinical, CMC and regulatory decisions made today support an efficient, credible path to BLA and global registration.

Responsibilities

• The successful leader will:
  • Define global regulatory strategy across the lead oncology 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
• The ideal candidate has personally led at least one BLA, with MAA experience strongly preferred, and brings experience in oncology, complex biologics, RNA therapeutics, cell or gene therapy, cancer vaccines or another advanced modality. The company is open to a senior consultant, fractional executive, interim leader or full-time SVP-level hire.

Required Skills

• Advanced scientific or medical degree preferred
• 15+ years in biopharma regulatory affairs
• VP/SVP-level leadership experience
• Direct leadership of at least one successful BLA; MAA experience preferred
• Background in oncology and complex modalities, including nucleic acid therapeutics
• Strong FDA interaction and regulatory CMC experience
• Small biotech or consulting experience strongly preferred