Senior Global Pharma Regulatory Counsel

Genentech; San Francisco (CA); On-site; USD 204,000 - 378,000; Full time

Job summary

Genentech in South San Francisco is seeking a Senior Corporate Counsel (Global TechOps & Pharma Quality) to provide global regulatory and transactional counsel for the Pharma Manufacturing unit.

You will partner with PT Quality and Regulatory leaders, advise on FDA/cGMP inspections, draft quality agreements, supervise outside counsel, and help ensure manufacturing compliance across sites worldwide.

Qualifications

• 7+ years of experience with US FDA/cGMP in pharma/biotech corporate or law firm.
• J.D. and active bar admission or eligible for CA In-House Counsel.
• Experience with manufacturing quality/regulatory matters is preferred.

Responsibilities

• Advise on FDA/cGMP regulatory and manufacturing compliance matters.
• Provide legal risk guidance to PT Global Head of Quality and Regulatory.
• Support US FDA facility inspections and foreign health authority inspections.
• Draft and negotiate quality-related agreements with external manufacturers.
• Manage outside counsel for relevant legal matters.
• Collaborate with cross-functional teams to ensure quality and regulatory alignment.

Skills

Regulatory counseling

Legal risk guidance

Communication skills

Team collaboration

Willingness to travel

Education

J.D. degree

Bar admission or CA eligibility

Job description

Genentech in South San Francisco is seeking a Senior Corporate Counsel (Global TechOps & Pharma Quality) to provide global regulatory and transactional counsel for the Pharma Manufacturing unit.

You will partner with PT Quality and Regulatory leaders, advise on FDA/cGMP inspections, draft quality agreements, supervise outside counsel, and help ensure manufacturing compliance across sites worldwide.