Regulatory CMC Senior Manager Opportunity
1 week ago
Vera Therapeutics is a biotechnology company dedicated to developing treatments for serious immunological diseases.
We are seeking a skilled Senior Manager, Regulatory CMC to join our fast-paced and collaborative team. This role will involve working with cross-functional teams to lead and support regulatory submissions and activities in the US and globally.
The successful candidate will have a strong background in Regulatory Affairs, particularly in the interpretation of regulatory requirements in the US region. They will also possess excellent organizational skills, with the ability to track multiple timelines in parallel and manage deadlines.
This position offers a competitive salary, estimated at $175,000 per annum, as well as opportunities for annual performance incentives and ongoing performance-based equity. We also offer a range of benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and paid holidays.
In this role, you will be responsible for managing clinical and CMC aspects of clinical products in early-to-late development, creating high-quality regulatory submissions that support product development strategy. You will also represent Regulatory Affairs on cross-functional project teams, evaluate proposed manufacturing changes, and establish internal regulatory processes.
Key qualifications for this position include a Bachelor's degree in a scientific field and 6+ years of relevant experience in Regulatory Affairs. Strong knowledge and experience in CMC development of biologics is preferred, as is experience with a regulatory information management system such as Veeva Vault RIM.
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