Senior Manager, Regulatory CMC

United States·Brisbanesenior

Legal & ComplianceRegulatory

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Quick Summary

Key Responsibilities

Proactively manage CMC aspects of clinical products in early-to-late development to create high quality regulatory submissions that support product development strategy.

Technical Tools

Legal & ComplianceRegulatory

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 www.veratx.com.

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.

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 for working with the cross-functional team to lead and support regulatory submissions and activities in the US and globally to support development programs.

Responsibilities

~1 min read

→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.

Requirements

~2 min read

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 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.

Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.

To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.

Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.