Senior Manager, Regulatory CMC

Vera Therapeutics, Inc. • Brisbane, CA

1d • $140,000 - $214,000

About The Position

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. 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.

Requirements

• 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.

Nice To Haves

• Industry experience in CMC development of biologics preferred.
• Experience with a regulatory information management system, such as Veeva Vault RIM a plus.

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.

Benefits

• 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 $140,000—$214,000 USD

What This Job Offers

• Job Type: Full-time
• Career Level: Senior