Senior Vice President, Regulatory Affairs
About The Position
The Senior Vice President/Vice President, Regulatory Affairs, is responsible for developing and executing global regulatory strategies aimed at the most efficient regulatory pathway for ORIC’s development programs. This position involves shaping and leading the long-term regulatory strategy and vision across all phases of development, providing oversight in planning product development strategies (including non-clinical, clinical, and post-approval), overseeing the company’s development pipeline from preclinical through commercialization, interacting regularly with global regulatory authorities, overseeing global regulatory submissions across multiple regions, and building internal systems to support successful submissions of multiple IND/CTA/NDA/MAA/PMA applications. Further, the Vice President, Regulatory Affairs, is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation, health authority regulations and guidances, and driving a culture of quality and accountability across the organization.
Requirements
- Advanced degree (PhD, PharmD, MD, or MS) in a life sciences or health-related discipline desired
- At least 15 years of biopharma regulatory and quality experience, with 10+ years focused on oncology and late-stage development, including post-regulatory approval product launch experience
- Previous experience directing and coordinating FDA and other Health Authority interactions
- Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval
- Experience with electronic filings (e.g., eCTD)
- Alignment with the company’s core values: empowering employees, executing with excellence, embracing challenges, fostering inclusivity, remaining humble and hopeful, and maintaining a patient-centered focus
Responsibilities
- Provide oversight for global regulatory affairs in all major regions (North America, Europe, Asia Pacific, Latin America) for all regulatory functions, including Clinical, Non-clinical, Regulatory Operations, and broad oversight for Regulatory CMC and Regulatory Diagnostics
- Represent ORIC and act as a company spokesperson (or delegate with oversight) in communications with regulatory authorities
- Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
- Provide strategic input on all regulatory activities in support of product development plan, lifecycle management, and post-approval planning
- Supervise and develop regulatory direct reports
- Provide management with regulatory due diligence advice for potential new product opportunities
- Grow corporate, project and industry knowledge
- Analyze and communicate current Regulatory issues and information to senior management and other departmental personnel.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
Number of Employees
11-50 employees
