Regulatory Affairs Expert for Biologics Development

4 days ago

Brisbane, California, United States Vera Therapeutics Full time

About Vera Therapeutics

Vera Therapeutics Inc. is a late-stage biotechnology company dedicated to developing treatments for serious immunological diseases. Our mission is to advance innovative therapies that address the root causes of these conditions, aiming to change the standard of care for patients worldwide.

Our lead product candidate, atacicept, is a fully humanized fusion protein designed to block 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. This therapy has shown promise in treating IgA nephropathy (IgAN).

We are also exploring the potential of atacicept in other immunologic disorders, demonstrating our commitment to expanding its therapeutic applications.

In addition to atacicept, we are developing MAU868, a monoclonal antibody targeting BK Virus, a polyomavirus that can have severe consequences in certain settings, such as kidney transplant.

Position Overview

We are seeking an experienced Regulatory Affairs professional to join our fast-paced team as a Senior Manager, Regulatory CMC. This individual will report directly to the Senior Director of Regulatory CMC and play a critical role in supporting regulatory submissions and activities in the US and globally.

The successful candidate will be responsible for managing clinical and CMC aspects of our products, ensuring high-quality regulatory submissions that align with our development strategy.

Main Responsibilities

  • Proactively manage clinical and CMC aspects of our products, creating comprehensive regulatory submissions that meet current regional requirements.
  • Author and review Clinical and CMC modules of applications and amendments for submission, guaranteeing complete and accurate regulatory content.
  • Represent Regulatory Affairs on cross-functional project teams, ensuring seamless collaboration and communication.
  • Evaluate proposed manufacturing changes, assessing their impact on existing filings and providing strategic guidance for optimal implementation.
  • Develop and implement internal regulatory processes, authoring and reviewing SOPs and Work Instructions to ensure consistency and integration across functions.
  • Coordinate, track, and prioritize regulatory activities and resources, guaranteeing functional, consistent, and integrated workflows that reflect cross-functional dependencies.
  • Determine risk assessments and implement regulatory strategies for products in early-to-late development, ensuring compliance with relevant regulations.

Qualifications

  • Bachelor's degree in a scientific field and 6+ years of relevant experience in Regulatory Affairs, commensurate with the role.
  • Strong knowledge and experience in interpreting regulatory requirements, with particular emphasis on the US region.
  • Excellent organizational skills, with the ability to manage multiple timelines in parallel and meet deadlines.
  • Exceptional written and verbal communication skills, with the ability to collaborate effectively across functions.
  • Strong problem-solving skills and attention to detail, with experience communicating regulatory strategies to stakeholders.
  • Industry experience in CMC development of biologics preferred.
  • Experience with a regulatory information management system, such as Veeva Vault RIM, a plus.

Compensation

This position offers an estimated annual salary of $175,000, based on industry standards and the candidate's qualifications, skills, and experience.

As a valued member of our team, you will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Additionally, you will enjoy a range of benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and paid holidays.

About Our Culture

Vera Therapeutics is committed to fostering a culture of fairness, equality, and mutual respect. We strive to provide our employees with a total compensation package that is market competitive and reflects our values of innovation, collaboration, and patient-centricity.

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