Vera Therapeutics, Inc.

Senior Manager, Regulatory CMC

Brisbane, CA · Senior

Sponsorship not specified$140k-$214kDetected 9 days ago

ComplianceFDA RegulatoryCommunicationProblem SolvingOrganizational SkillsRegulatory Affairs

About the role

Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and collaborative team.

Responsibilities

Proactively manage CMC aspects of clinical products in early-to-late development to create high quality regulatory submissions that support product development strategy.
Establish and implement internal regulatory processes, author and review SOPs and Work Instructions.
Determine risk assessment and implement regulatory strategies for products in early-to-late development.
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.

Requirements

Strong knowledge and experience in interpretation of global regulatory requirements, with particular emphasis on the US region.
Experience communicating regulatory strategies to stakeholders.
BA/BS in a scientific field and a minimum of 6 years of relevant experience.
If you are unsure if a message is from Vera Therapeutics, please email human resources.
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.
Demonstrated regulatory affairs experience commensurate with the role
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 USD
At 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.

Nice to have

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

Compensation

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.

Company info

Vera Therapeutics was founded in 2016 and is based in Brisbane, California.
At Vera, our values are the cornerstone of our culture and guide how we work together every day.
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.

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