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
- 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*