Oncology Regulatory Strategy Director | BLA Expert

Scorpion Therapeutics; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Director or VP of Regulatory Affairs to lead regulatory strategy, submissions, and agency interactions for oncology therapeutics. This role drives global regulatory plans and supports product development with a focus on achieving successful BLA approvals.

The position requires extensive experience in US and global regulatory affairs, leadership of cross-functional teams, and a track record of BLA submissions for oncology drugs.

Qualifications

• Advanced life sciences degree with 12+ years industry experience, or Bachelor’s with 15+ years.
• 5+ years of senior regulatory leadership, with proven success in BLA submissions for oncology drugs.
• Deep knowledge of US and global regulatory landscapes; experience managing external vendors and cross-functional teams.

Responsibilities

• Develop global regulatory strategies for oncology programs.
• Oversee IND/BLA filings and ensure timely submissions.
• Manage relationships with health authorities (FDA, EMA) and align regulatory plans with clinical, CMC, quality, and commercial functions.
• Build and lead the regulatory function and mentor teams.
• Provide strategic guidance to executive leadership.

Skills

Regulatory leadership

Strategic regulatory planning

Cross-functional leadership

Education

Advanced life sciences degree

Bachelor's degree in life sciences

Job description

Scorpion Therapeutics is seeking a Senior Director or VP of Regulatory Affairs to lead regulatory strategy, submissions, and agency interactions for oncology therapeutics. This role drives global regulatory plans and supports product development with a focus on achieving successful BLA approvals.

The position requires extensive experience in US and global regulatory affairs, leadership of cross-functional teams, and a track record of BLA submissions for oncology drugs.