Job Description

Reporting to the Senior Vice President of Regulatory & Quality, this position is specifically responsible for the oversight of regional and global regulatory clinical submissions and to develop strategies to support therapeutic area direction and corporate objectives.

Responsibilities:

• Provides strategic direction and oversight in the preparation of regulatory submissions.
• Leads teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective project management oversight, direction, planning, and execution.
• Develop and contribute to content, format and accountability for regulatory submissions and related amendments and supplements and, including preparation of meeting requests, briefing packages, orphan drug designation applications, NDAs/BLAs, and other regulatory submissions as applicable.
• Acts as regulatory representative on project teams by identifying, tracking and delivering on key milestones/objectives.
• Acts as back up to Senior Vice President, Regulatory & Quality on an as needed basis.
• Responsible for submission preparation tracker including follow-up with authors/reviewers to meet or exceed timeline expectations.

Qualifications:

• Bachelor’s Degree or higher in biology, chemistry, or related life-sciences discipline.
• 10+ years of experience in the pharmaceutical industry providing strategic direction and oversight in the preparation of regulatory submissions.
• Proven ability to lead teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective project management oversight, direction, planning, and execution.
• Experienced in developing and contributing to content, format and accountability for regulatory submissions and related amendments and supplements and, including preparation of meeting requests, briefing packages, orphan drug designation applications, NDAs/BLAs, and other regulatory submissions as applicable.
• Strong track record as acting regulatory representative on project teams by identifying, tracking and delivering on key milestones/objectives.
• Experienced in supporting leadership as back up to Senior Vice President, Regulatory & Quality on an as needed basis.

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. For this role, the anticipated base pay range is $180,000 - $235,000. 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.

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