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*