Vice President, Regulatory Affairs

Role and Responsibilities

  • Sets vision and direction through resource allocation decisions for Regulatory Affairs department
  • Oversees and directs all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies
  • Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, including collaborating on protocols and written submissions, etc.
  • Provides counsel to other Corvus departments.
  • Ensures timely preparation of organized and scientifically valid applications
  • Provides expertise in translating regulatory requirements into practical, workable plans
  • Interacts with regulatory agencies, including the FDA and international regulatory organizations.
  • Develops and implements strategic plans and objectives for the organization in alignment with corporate strategy
  • Oversees direction and approves tactical administrative or operational policies and resource allocation decisions to ensure achievement of corporate objectives
  • Develops strategic plans to ensure successful implementation of action plans and objectives where analysis of situations or data requires an in-depth knowledge of the company, competitive environment, technology and economic or social implications of organization activities
  • Participates in the development of corporate methods, techniques and evaluation criteria for projects, programs and people
  • Approves budgets and schedules to meet corporate requirements
  • Interacts with internal and external industry leaders regarding highly visible projects and activities, while influencing or negotiating matters of great significance on behalf of the company
  • Has overall control of planning, staffing, budgeting, managing expense priorities, and approving changes to methods and practices
  • Manages a team of individual contributors and consultants.

Qualifications and Education Requirements

  • Bachelor’s degree required
  • 10+ years of related experience required
  • 4+ years of broad international regulatory experience

Preferred Skills

  • Excellent teamwork and collaboration skills 
  • Proficient with Microsoft Office.
  • Able to build effective working relationships throughout the organization internally and externally to achieve goals.
  • Flexibility and willingness to solve problems that fall outside of immediate area of expertise
  • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
  • Work independently in an interdisciplinary, fast-paced, often changing environment.
  • Committed to the values of integrity, accountability, transparency, and drive.
  • Deep experience in IND, NDA and/or BLA filings in US and foreign countries
  • Experience in drugs and biologics in areas of oncology, immunology and infectious diseases

  *LOCAL Bay Area Candidates ONLY*