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VP Regulatory Affairs

Regulatory | South San Francisco, CA | Full Time

Job Description

About the Company & Role:

Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for immunological and Inflammatory diseases that improve patients’ lives.  We are seeking a highly skilled and motivated VP of Regulatory Affairs to join a fast-paced and collaborative team. The VP of Regulatory Affairs will be the senior leader for all regulatory strategy, filings, communications, and negotiations for the company.

 

Responsibilities:

  • Directs and coordinates regulatory activities working with the Executive Team in formulating strategy, overseeing global regulatory submissions, interpreting regulatory requirements and feedback, and administering policies relevant to this critical functional area
  • Leads the Regulatory function hiring, managing, and developing personnel as needed
  • Provides input into develop plans along with CMO, CDO, and the rest of the development team
  • Formulates and drives strategy, but also plays a hands-on role in regulatory submissions
  • Serves as point of contact and represents the Company before regulatory authorities, including preparation of meeting agendas, materials, minutes and interpretation of regulatory correspondence
  • Oversees development and refinement of regulatory policies, procedures and SOPs within the corporate infrastructure context
  • Understanding and awareness of the competitive regulatory environment ensuring to keep the rest of the leadership team informed of any changes to requirements
  • Provides strategic leadership and key insights that will allow the organization to operate collaboratively as well as proactively
  • Ability to think and manage strategically, with an attention to detail, focus, and a sense of urgency

 

Qualifications:

  • BS or higher in life sciences or health-related field preferred
  • 12+ years regulatory pharmaceutical experience
  • A proven track record working in a cross-functional team environment representing the regulatory function, including experience with FDA, EMA and global regulatory authorities
  • Phase 3 experience and NDA/ BLA/ or MAA preparation or submission experience
  • Deep familiarity with drug development process
  • Regulatory experience with Biologics
  • Regulatory experience with rheumatology or rheumatological related clinical indications within the last 5 years
  • Strong leadership, management, and mentorship skills
  • Strong interpersonal skills with excellent oral as well as written communications with a proven track record working with and presenting to an executive management team, board members and external thought leaders
  • Ability to work independently as well as collaboratively in cross-functional team environment
  • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Project)
  • Innovative, analytical and extremely organized to drive projects to completion
  • A willingness to work in a fast-paced start up environment

 Vera Therapeutics Inc. is an equal opportunity employer.