Manager, Regulatory Operations

Vera Therapeutics, Inc.; Oregon; Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Vera Therapeutics, Inc. is seeking a Manager, Regulatory Operations to join the Regulatory Operations and Publishing teams in California. You will support submission activities, formatting, template development, PDF publishing, and eCTD processes.

You will work with cross-functional teams to prepare IND/NDA/BLA submissions, maintain submission templates, and ensure regulatory style guide compliance across documents. Proficiency in MS Word, Adobe, and Veeva Vault RIM is essential.

Qualifications

• Bachelor's degree and 5-6 years of Regulatory Operations experience.
• Expert Word processing, formatting, and PDF publishing for submissions.
• Experience with electronic document management and publishing systems (Veeva Vault RIM, Box, SharePoint).
• Proficiency with MS Word and Adobe.
• Independent worker with strong communication and timing skills.
• Flexible and detail oriented in a regulatory context.

Responsibilities

• Prepare, publish, and compile regulatory submission documents for various applications (IND, NDA/BLA, MAA, CTA, NDS).
• Collaborate with regulatory and cross-functional teams to improve processes using Veeva Vault RIM.
• Format complex Word docs with tables/graphs; maintain submission templates and styles.
• Manage literature lists and obtain copies as required for submissions.
• Create bookmarks/hyperlinks and ensure consistency with style guides.
• Support lifecycle maintenance for IND and BLA submissions as needed.
• Conduct final quality review of published documents prior to dispatch.
• Archive regulatory information management files for traceability.

Skills

MS Word

Adobe Acrobat

Word processing

PDF publishing

Veeva Vault RIM

eCTD submissions

Regulatory Ops

Education

Bachelor's degree

Tools

Veeva Vault RIM

Box

SharePoint

Lorenz DocuBridge

eCTD Tools

Job description

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics' flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand ( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit .At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner's mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.

Position Summary

Reporting to the Associate Director, Regulatory Operations and Publishing, the Manager, Regulatory Operations will be a key contributor to Vera Therapeutics' Regulatory Operations and Regulatory Affairs teams with accountability 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, publishing, and compilation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, NDA/BLA, MAA, Swissmedic, 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)
• Format complex Word documents to generate compliant regulatory documents including complicated tables and graphs created in a variety of formats. Maintain the internal regulatory styles template and manage submission templates.
• Maintaining the list of literature for regulatory submissions and obtaining copies of literature, as needed.
• 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 and formatting standards.
• Support ongoing regulatory lifecycle maintenance submissions for IND and BLA applications, as needed.
• Conduct final quality review of published documents and submissions to ensure consistency and compliance with regulatory requirements prior to dispatch.
• Maintain and archive regulatory information management task including archiving regulatory documents, Health Authority Correspondence, submission records, and final published files within Veeva Vault RIM to ensure document traceability and completeness.
• Maintain current knowledge of global regulatory submission requirements, eCTD standards, electronic submission specifications, and Health Authority requirements.
• Perform other duties as assigned

Qualifications

• Bachelor's degree and 5-6 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, Box, SharePoint, Lorenz DocuBridge, eCTD Validation and viewing tools) and other formatting, publishing and QC tools (TRS Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations.
• Proficiency with MS Word and Adobe is a MUST. Knowledge of Accenture StartingPoint Templates is a plus.
• Committed to producing high quality and timely deliverables.
• Work independently and efficiently with Regulatory Affairs.
• Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.

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$120,000—$170,000 USDAt Vera, base pay is only one part of your total compensation package.

The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

• Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.