{"id":2880411,"url":"https://alion.io/job/vera-therapeutics-manager-regulatory-operations","title":"Manager, Regulatory Operations","company":{"id":2087869,"name":"Vera Therapeutics","domain":"veratx.com","url":"https://alion.io/company/veratx","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":120000,"max":170000,"currency":"USD","period":"year","gross":null,"usd_annual":170000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SharePoint","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-19T21:22:25Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-24T21:56:06Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"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 www.veratx.com.\nAt 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. \nPosition Summary:\nReporting 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.\n\nResponsibilities:\nAssist 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).\nWork 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)\nFormat 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.\nMaintaining the list of literature for regulatory submissions and obtaining copies of literature, as needed.\nFormat, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes.\nEnsure consistency across regulatory submission documents following the regulatory style guide and formatting standards.\nSupport ongoing regulatory lifecycle maintenance submissions for IND and BLA applications, as needed.\nConduct final quality review of published documents and submissions to ensure consistency and compliance with regulatory requirements prior to dispatch.\nMaintain 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.\nMaintain current knowledge of global regulatory submission requirements, eCTD standards, electronic submission specifications, and Health Authority requirements.\nPerform other duties as assigned\n\nQualifications:\nBachelor’s degree and 5-6 years of experience in Regulatory Operations with specialized skills in electronic submissions.\nIn depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions.\nRelevant 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.\nProficiency with MS Word and Adobe is a MUST. Knowledge of Accenture StartingPoint Templates is a plus.\nCommitted to producing high quality and timely deliverables.\nWork independently and efficiently with Regulatory Affairs.\nDemonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.\nVera Therapeutics Inc. is an equal-opportunity employer.\nVera 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.\nFor this role, the anticipated base pay range is\n$120,000—$170,000 USD\nAt 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.\nNotice to Recruiters/Staffing Agencies\nRecruiters 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.\nWe require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.\nVera 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.\nFraud Alert\nTo 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/.\nRecruiters 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.\nCA Privacy Notice\nApplicants residing in California should review our California Privacy Notice for Employees, Job Applicants, and Contractors, which describes the categories of personal information we collect, how we use it, and your privacy rights under the California Consumer Privacy Act, as amended by the California Privacy Rights Act: https://veratx.com/ca-privacy/.","description_format":"text","description_chars":6802,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Flexible time off","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-19T22:38:12Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":217500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":35,"reasons":["conf:3","win:early"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":170000,"is_top_pay":false},"html_url":"https://alion.io/job/vera-therapeutics-manager-regulatory-operations","json_url":"https://alion.io/job/vera-therapeutics-manager-regulatory-operations.json","meta":{"generated_at":"2026-10-24T22:39:25Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":33283,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2087869},"rest":"https://alion.io/mcp/rest/get_company?id=2087869"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fvera-therapeutics-manager-regulatory-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fvera-therapeutics-manager-regulatory-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fvera-therapeutics-manager-regulatory-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/vera-therapeutics-manager-regulatory-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvera-therapeutics-manager-regulatory-operations"}]}