Senior Manager, Regulatory CMC

Responsibilities

• Proactively manage CMC aspects of clinical products in early-to-late development to support product development strategy.
• Author and review CMC modules of applications and amendments for submission, ensuring compliance with regional requirements.
• Represent Regulatory Affairs on cross-functional project teams.
• Evaluate proposed manufacturing changes for impact on existing filings and provide strategic regulatory guidance.
• Establish and implement internal regulatory processes, including the authorship and review of SOPs and Work Instructions.
• Coordinate, track, and prioritize regulatory activities and resources to reflect cross-functional dependencies.
• Determine risk assessments and implement regulatory strategies for products in various stages of development.
• Ensure ongoing regulatory compliance with all relevant global regulations.

Requirements

• BA/BS in a scientific field.
• Minimum of 6 years of relevant regulatory affairs experience.
• Strong knowledge and experience in interpreting global regulatory requirements, with a particular emphasis on the US region.
• Excellent written and verbal communication skills with the ability to collaborate across functions.
• Strong organizational skills and the ability to manage multiple parallel timelines and deadlines.
• Strong problem-solving skills and high attention to detail.

Preferred Qualifications

• Industry experience in the CMC development of biologics.
• Experience with regulatory information management systems, such as Veeva Vault RIM.

About the Company

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. We are currently advancing a pipeline of innovative therapies, including atacicept and VT-109, to address B-cell-mediated diseases such as IgA nephropathy and lupus nephritis.