Vera Therapeutics, Inc. · 3 days ago
Executive Director, Commercial Regulatory Affairs
Brisbane, CA
Full-time
Onsite
Director/Executive
$238K/yr - $363K/yr
12+ years expVera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Executive Director of Commercial Regulatory Affairs will oversee post-approval regulatory activities, ensuring compliance with FDA regulations and acting as a strategic liaison among various departments to support product launches and lifecycle management.
BiotechnologyHealth Care
Responsibilities
Lead regulatory strategy for advertising and promotion across IgAN products, including marketed and pipeline compounds
Lead the Regulatory review and guidance for the promotional review committee (MLR or PRC or equivalent), providing final regulatory approval for externally facing promotional and disease awareness materials
Act as the primary liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) for advisory comment submissions, enforcement communications, or claim negotiations
Ensure consistency and compliance of all advertising and labeling across global markets and channels, including social media and digital marketing
Oversee regulatory submissions related to promotional materials and labeling content updates, supporting U.S. Prescribing Information (USPI) and related documents, and global labeling harmonization
Develop and update standard operating procedures (SOPs) for the content review and approval process, ensuring efficient documentation and regulatory compliance
Mentor regulatory staff and train cross-functional teams on new FDA guidances and emerging enforcement trends
Collaborate with commercial, medical, and legal departments to align marketing and communications with the latest regulatory standards and risk management practices
Identify and mitigate regulatory risks in advertising and promotion, implementing corrective measures proactively
Participate or lead other post-approval life cycle regulatory activities, as needed
Qualification
Required
Bachelor's degree in health or life sciences; advanced degree (PharmD, PhD, or MS) strongly preferred
12+ years of regulatory advertising and promotion experience within the pharmaceutical or biotechnology industry
Direct experience liaising with FDA's OPDP or APLB and handling advisory comments, enforcement letters, or claim rationale packages
Proven leadership in chairing ad/promo review committees and mentoring regulatory professionals
Demonstrated ability to integrate scientific, legal, and commercial considerations into sound regulatory decisions
Company
Vera Therapeutics, Inc.
Vera Therapeutics, Inc.
201-500 employees
H1B Sponsorship
Vera Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Oxford Finance LLCAbingworth
2025-12-09Post Ipo Equity· $261M
2025-06-03Post Ipo Debt· $75M
2024-10-28Post Ipo Equity· $300M
Leadership Team
David L. Johnson
Chief Operating Officer
Kerry Cooper
Senior Vice President Medical Affairs
Recent News
2026-01-16
2026-01-11
The Motley Fool
2026-01-08
Company data provided by crunchbase