Manager, Regulatory Operations

The company the company is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company the company’ flagship commercial product is TRUTAKNA TM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand  ( APRIL) inhibitor. The company the company is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. The company the company was founded in 2016 and is based in Brisbane, California. To learn more, visit  [link for members] .

At the company, 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 the company the company’ 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.

The company the company Inc. is an equal-opportunity employer.

The company the company 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 USD

At the company, 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. The company the company 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.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact the company the company 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.

The company the company’ 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 the company the company and such organization and will be considered unsolicited and the company the company 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 the company the company, recruiters only direct candidates to apply through our official career page at  [link for members] .

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 the company the company, please email human resources.

CA Privacy Notice

Applicants 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:  [link for members] .