Senior Program Director, Commercial Regulatory Affairs

Genentech; South San Francisco (CA); On-site; USD 120,000 - 223,000; Full time

Benefits offered by this job

Discretionary bonus

Job summary

Genentech, located in South San Francisco, CA, seeks an Associate Program Director for Commercial Medical Legal Regulatory Review to lead cross-functional CMLRs and provide regulatory guidance across products and campaigns. The role requires directing regulatory strategy, ensuring compliance with FDA and Roche policies, and collaborating with commercial leaders on promotional materials.

The candidate should bring 5+ years in bio/pharma regulatory roles, with advanced degrees preferred, and

Qualifications

• Bachelor's degree in life sciences, law, public policy, marketing, business, education or related field is preferred.
• Graduate-level degree (JD, MBA, MS, PharmD or similar) strongly preferred.
• Minimum 5 years of experience in regulatory, legal, compliance, policy or related disciplines in bio/pharma.
• Experience in regulatory/commercial regulatory disciplines preferred.
• Working knowledge of bio/pharma regulatory environment and healthcare compliance.

Responsibilities

• Lead CMLRs and collaborate with cross-functional groups and advertising agencies.
• Provide regulatory support and guidance for products, business areas and projects.
• Manage departmental projects and address compliance issues proactively.
• Stay current in regulatory, healthcare compliance and ethics.
• Monitor CMLRs and provide management oversight for FDA communications, audits and compliance issues.
• Collaborate with commercial leadership to influence marketing strategies and approvals for promotional materials.
• Interpret FDA regulations and Roche policies for disease state and promotional materials.
• Provide regulatory input on commercial concepts and draft materials.
• Support FDA correspondence and follow-on submissions; represent CORA for CDS and US label development.

Skills

Decision making

Regulatory expertise

Cross-functional collaboration

Influencing & negotiation

Regulatory communication

Time management

Attention to detail

Process orientation

Resource identification

Education

Bachelor's degree

Graduate-level degree preferred

Job description

Genentech, located in South San Francisco, CA, seeks an Associate Program Director for Commercial Medical Legal Regulatory Review to lead cross-functional CMLRs and provide regulatory guidance across products and campaigns. The role requires directing regulatory strategy, ensuring compliance with FDA and Roche policies, and collaborating with commercial leaders on promotional materials.

The candidate should bring 5+ years in bio/pharma regulatory roles, with advanced degrees preferred, and