Head of Regulatory Affairs — Build & Lead IND Strategy

EPM Scientific; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive compensation

Equity options

Foundational leadership opportunity

High impact role

Job summary

A dynamic biotech company in San Francisco seeks a Head of Regulatory Affairs (VP/SVP) to build a regulatory organization from scratch. This role requires a strategic leader with over 15 years of regulatory affairs experience, specializing in IND filings and capable of developing teams and processes in a fast-paced environment. The position promises significant impact on organizational growth and involves leading regulatory strategy and interactions with the FDA. Competitive compensation and equity are offered.

Qualifications

• 15+ years of regulatory affairs experience within biotech/pharma.
• Demonstrated success leading IND filings and early-phase regulatory strategy.
• Experience building regulatory capabilities from the ground up.

Responsibilities

• Own global regulatory strategy across early development.
• Build and scale the regulatory function including hiring and establishing systems.
• Lead interactions with FDA and other health authorities.

Skills

Regulatory affairs leadership

IND filing experience

Strategic planning

Team building

Oncology expertise

Job description

A dynamic biotech company in San Francisco seeks a Head of Regulatory Affairs (VP/SVP) to build a regulatory organization from scratch. This role requires a strategic leader with over 15 years of regulatory affairs experience, specializing in IND filings and capable of developing teams and processes in a fast-paced environment. The position promises significant impact on organizational growth and involves leading regulatory strategy and interactions with the FDA. Competitive compensation and equity are offered.