Manager, Regulatory Operations
About the company
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 www.veratx.com.
About the role
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.
- Maintain the list of literature for regulatory submissions and obtain 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 tasks 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.