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VP Regulatory Affairs

Regulatory | South San Francisco, CA | Full Time

Job Description

About the Company & Role:

Vera Therapeutics Inc. is a clinical-stage biotechnology company developing innovative biologic therapeutics with transformative clinical potential. We seek a highly skilled and motivated VP of Regulatory Affairs and Quality to join a fast-paced and collaborative team. The VP of Regulatory Affairs and Quality will be the senior leader for all regulatory strategy, filings, communications, and negotiations for the company. Additionally, this person will be responsible for Vera’s Quality Systems.

Responsibilities:

  • Direct and coordinate regulatory activities and work with both the Project Team and the Executive Team in formulating strategy, overseeing global regulatory submissions, interpreting regulatory requirements and feedback, and administering policies relevant to this critical functional area. 
  • Lead and build both the Regulatory and Quality functions; hire, manage, and develop personnel. 
  • As a key member of the Project Team, provide input into development plans. 
  • Serve as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, minutes, and interpretation of regulatory correspondence. 
  • Ensure both ongoing compliance and audit readiness within the R&D organization.  
  • Oversee development and refinement of regulatory and quality policies, procedures, and SOPs within the corporate infrastructure context. 
  • Monitor the competitive regulatory environment and inform the leadership team accordingly. 

Qualifications:

  • 12+ years of regulatory experience. 
  • BS in biological/physical sciences required. An advanced degree is preferred. 
  • A proven track record working in a cross-functional team environment representing the regulatory function, including experience with FDA, EMA and global regulatory authorities.  
  • Deep familiarity with drug development process and experience with Biologics. 
  • Regulatory experience with nephrology or rheumatology related clinical indications. 
  • Mid and late-stage development experience and NDA/ BLA/ or MAA preparation and submission experience. 
  • Ability to work in a small/mid-sized company within a largely virtual environment; small biotech/pharma experience preferred. A willingness to work in a fast-paced start up environment. 
  • Strong leadership, management, and mentorship skills. Must be adept at formulating and driving strategy, but also playing a hands-on role in regulatory submissions. 
  • Ability to think and manage strategically, with attention to detail and a sense of urgency. 
  • Strong communication skills, both written and verbal, with a proven track record working with and presenting to the executive management team, board members and external thought leaders.  

 Vera Therapeutics Inc. is an equal opportunity employer.