Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com . Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: The Executive Director Commercial Regulatory Affairs oversees post-approval regulatory activities including but not limited to regulatory compliance for promotional and non-promotional materials, ensuring alignment with FDA regulations (primarily OPDP/APLB) and internal company policies. This role acts as the strategic liaison between Regulatory Affairs, Commercial, Medical Affairs, Legal, and Compliance to support product launches and lifecycle management. The role will report to the Senior Vice President of Quality and Regulatory. The ideal candidate will have a strong background in Regulatory science, Medical, Legal and Regulatory review processes and Regulatory compliance. 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. Qualifications: • 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. Vera Therapeutics Inc. is an equal-opportunity employer. Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. For this role, the anticipated base pay range is $238,000 - $363,000 USD Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/ . Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.
