Director, Clinical Regulatory Affairs

4 days ago

Brisbane, Queensland, Australia Vera Therapeutics, Inc. Full time

Title: Director, Clinical Regulatory Affairs

Location: Brisbane

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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:

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, 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, 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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