Senior Manager - Regulatory Operations and Publishing
To see similar active jobs please follow this link: Remote Management jobs
Title: Senior Manager, Regulatory Operations and Publishing
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. 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:
Reporting to the Executive Director, Regulatory Operations and GXP Information Systems, the Senior Manager, Regulatory Operations and Publishing 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 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 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 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 (e.g., Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge), eCTD Validation and viewing tools (e.g., Lorenz eValidator, EURS Validator) and other publishing and QC tools (PDF 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 MS Outlook, PowerPoint, Project, and Excel 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.
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. For this role, the anticipated base pay range begins at $187,000. 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.
At 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.
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.
About the job
Senior Manager - Regulatory Operations and Publishing
To see similar active jobs please follow this link: Remote Management jobs
Title: Senior Manager, Regulatory Operations and Publishing
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. 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:
Reporting to the Executive Director, Regulatory Operations and GXP Information Systems, the Senior Manager, Regulatory Operations and Publishing 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 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 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 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 (e.g., Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge), eCTD Validation and viewing tools (e.g., Lorenz eValidator, EURS Validator) and other publishing and QC tools (PDF 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 MS Outlook, PowerPoint, Project, and Excel 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.
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. For this role, the anticipated base pay range begins at $187,000. 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.
At 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.
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.