Regulatory Affairs Manager jobs in California

Title: Senior Manager, Regulatory Affairs

Location: Brisbane, CA or Remote

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

Vera is seeking a Senior Manager, Regulatory Affairs to join an experienced, fast-paced and collaborative team. The Senior Manager will report to the Director of Regulatory Affairs 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 a Phase 3 development program.

Responsibilities:

• Responsible for developing regulatory strategies and executing submissions to further the successful development of a Phase 3 program.
• Leading the cross functional team to develop responses to health authority questions globally, tracking and managing deadlines.
• Provide regulatory representation on key meetings, including study management team meetings. Responsible for independently researching options for regulatory strategies and presenting recommendations to teams.
• Participate and contribute to regulatory team meetings interfacing with functional areas including Clinical, Clinical Operations, and CMC.
• Lead the development of briefing documents for Agency meetings and provide substantial support for health authority interactions.
• Maintenance of US applications to ensure Agency compliance.
• Reviews clinical documentation including protocols, DSUR’s, IB’s, and others for compliance.
• Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
• May contribute to the development of process improvements and procedural documents.
• May support other programs.

Qualifications:

• Strong knowledge and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organization 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 3-6 years of relevant experience

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 starting base pay range for this position is $175,000 per year. 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.

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.

COVID-19 Policy

Vera’s top priority is the health and safety of our employees, their families and the communities where they live and work. As part of our commitment to health and safety, we require all U.S. employees to be fully vaccinated against COVID-19. If your role at Vera requires you to work or otherwise be on Vera’s premises, full or part-time, we require our employees to comply with Vera’s mandatory COVID-19 vaccination policy (currently requiring full vaccination). Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, may request a reasonable accommodation with Human Resources. Your employment is also subject to ongoing compliance with the mandatory vaccination policy and all other Vera policies, as they may be modified from time to time, at the sole discretion of Vera.

Notice to Recruiters/Staffing Agencies

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.