Senior Manager, Regulatory CMC

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. 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:

Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for working with the cross-functional team to lead and support regulatory submissions and activities in the US and globally to support development programs.

Responsibilities:

• Proactively manage CMC aspects of clinical products in early-to-late development to create high quality regulatory submissions that support product development strategy.
• Author and review CMC modules of applications and amendments for submission, ensuring complete regulatory content that meets current regional requirements.
• Represent Regulatory Affairs on cross-functional project teams.
• Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes.
• Establish and implement internal regulatory processes, author and review SOPs and Work Instructions.
• Coordinate, track, and prioritize regulatory activities and associated resources, ensuring they are functional, consistent, and integrated to reflect cross-functional dependencies.
• Determine risk assessment and implement regulatory strategies for products in early-to-late development.
• Ensure regulatory compliance with relevant regulations.

Qualifications:

• Strong knowledge and experience in interpretation of global regulatory requirements, with particular emphasis on the US region.
• Strong organizational skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Strong problem-solving skills and attention to detail.
• Experience communicating regulatory strategies to stakeholders.
• Demonstrated regulatory affairs experience commensurate with the role; BA/BS in a scientific field and a minimum of 6 years of relevant experience.
• Industry experience in CMC development of biologics preferred.
• Experience with a regulatory information management system, such as Veeva Vault RIM a plus.

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.