Vice President, Regulatory Affairs

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ 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 (IgAN) and lupus nephritis.

Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next‑generation fusion protein targeting BAFF and APRIL, known as VT‑109, with wide therapeutic potential across the spectrum of B‑cell‑mediated diseases. Vera Therapeutics is also evaluating the development of MAU
868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT‑109, and MAU
868. For more information, visit

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.

The Vice President, Regulatory Affairs will be responsible for the development and execution of the company’s Regulatory strategy and report into the Senior Vice President, Regulatory and Quality
. This critical hire will provide input, prioritize, implement, monitor, and communicate Vera’s Regulatory strategy and programs. As part of the Quality and Regulatory leadership team, you will establish and translate Vera’s Regulatory strategy into operational policies, processes, procedures, and training to meet global regulatory, medical/health, and legislative standards. This role requires experience, knowledge, and leadership credibility to be effective across Vera in multiple capacities, thereby ensuring compliance with Regulatory standards and corporate‑wide commitment to Quality principles and Vera values.

• In this highly visible role, the successful candidate will develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals.
• Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions.
• Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations.
• Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre‑submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
• Partner closely with cross‑functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration.
• Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements.
• Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments.
• Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions.
• Establish and…