Senior Manager, Regulatory CMC

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit .At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney. 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 forworking with the cross-functional teamto 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.Vera Therapeutics Inc. is an equal-opportunity employer.Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. 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 USDAt Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.Notice to Recruiters/Staffing AgenciesRecruiters and staffing agencies should not contact Vera Therapeutics through this page. 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