Manager, Clinical Regulatory

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 MAU868, 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 MAU868. For more information, please 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.

Position Summary

Vera is seeking a Manager, Clinical Regulatory, to join an experienced, fast-paced and collaborative team. This role will report to the Associate Director, Clinical Regulatory and will be responsible for working with the cross-functional team to support regulatory submissions and activities in the US and globally across development programs. The Manager will also support broader Clinical Regulatory functional activities.

Responsibilities

• Proactively manage regulatory aspects of clinical studies in early to late development to create high quality regulatory submissions that support product development strategy.
• Author and review Clinical modules of applications and amendments for submission, ensuring complete regulatory content that meets current regional requirements.
• Represent Clinical Regulatory Affairs on cross-functional project teams.
• Evaluate proposed clinical protocol changes for impact to existing filings and provide strategic regulatory guidance for optimal implementation of changes.
• Establish and implement internal regulatory processes, including authoring and review SOPs and Work Instructions.
• Coordinate, track, and prioritize regulatory activities and associated resources, ensuring they are functional, consistent, and integrated to reflect cross-functional dependencies.
• Determine risk assessment and implement regulatory strategies for products in early-to-late development.
• Ensure regulatory compliance to relevant regulations.

Qualifications

• BA/BS in a scientific field and 3-5 years of relevant experience.
• Knowledge and experience in interpretation of regulatory requirements, with particular emphasis on US regulations.
• Strong organizational skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Strong problem-solving skills and attention to detail.
• Experience communicating regulatory strategies to stakeholders.
• Demonstrated Regulatory Affairs experience commensurate with the role.
• Industry experience in CMC development of biologics preferred.
• Experience with a regulatory information management system, such as Veeva Vault RIM a plus.

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 $116,000 — $176,000 USD.