Senior Manager, Regulatory Operations and Publishing

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 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 Sr. Manager, Regulatory Operations and Publishing will report to the Executive Director, Regulatory Operations and GxP Information Systems and will be responsible for submission activity by supporting cross‑functional departments. Primary responsibilities will include Word document processing/formatting, template development and management, PDF publishing and review, eCTD Publishing, review and archiving consistent with global regulatory requirements for different application types.

Responsibilities:

• Assist the Regulatory Operations Lead in the preparation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, BLA/sBLA, MAA, CTA, NDS).
• Work with Regulatory Operations Lead, subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions, and Submissions Archive)
• Manage the preparation and submission of preclearance and Form 2253 promotional material submissions to the U.S. FDA through the Office of Prescription Drug Promotion (OPDP), ensuring completeness, accuracy, and compliance with regulatory requirements and timelines, while leveraging Veeva PromoMats to manage promotional materials and submission documentation in alignment with internal review and approval processes.
• Partner with Regulatory Affairs and MLR teams to ensure Promotional Review Committee (PRC) approved materials are finalized and submitted in accordance with FDA postmarketing promotional submission requirements.
• Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs created in a variety of formats. Maintain the internal regulatory styles template and manage submission templates.
• Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes.
• Ensure consistency across regulatory submission documents following the regulatory style guide.
• Provide technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.
• Provide input for scheduling and planning submission timelines in collaboration with Regulatory Operations Lead.
• Coordinate with external publishing vendors and consultants for on-time delivery of high quality regulatory submissions.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving regulatory submission documents/correspondence.
• Participate in the development of Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.
• Maintain knowledge of global regulatory submission requirements.
• Other duties as assigned

Qualifications:

• Bachelor’s degree and 5+ years of experience in Regulatory Operations with specialized skills in electronic submissions.
• In depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions.
• Relevant experience with electronic document management and publishing systems (eg, Veeva Vault RIM, Veeva Vault PromoMats, Box, SharePoint, Lorenz DocuBridge), eCTD Validation and viewing tools (eg, Lorenz eValidator, EURS Validator) and other formatting, publishing and QC tools (StartingPoint Templates and TRS Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations.
• Proficiency with MS Word and Adobe is a MUST. Knowledge of MS Outlook, PowerPoint, Project, and Excel is a plus.
• Committed to producing high quality and timely deliverables.
• Work independently and efficiently.
• Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.

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.