Vice President, Regulatory Affairs & Quality Assurance

Company Description

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California.

 

Job Description

The Vice President, Regulatory Affairs & Quality Assurance, is responsible for developing and executing global regulatory strategies aimed at the most efficient regulatory pathway and ensuring quality compliance for ORIC’s development programs. This position involves shaping and leading the long-term regulatory strategy and quality operations 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 & Quality Assurance, 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.

DUTIES AND 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 and quality affairs 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.
• Oversee stage-specific development, implementation, and monitoring of all GXP activities via management of the Quality Affairs Department
• Ensure GXP compliance across clinical operations, CMC, and supply chain functions
• Lead preparation for and management of regulatory inspections, including pre-approval inspections
• (PAIs)

Qualifications

QUALIFICATIONS:

• 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
• Strong experience with GXP compliance and building quality systems (QMS) in a development-stage and/or commercial environment
• Experience with electronic filings (e.g., eCT)

Additional Information

The anticipated salary range for candidates is between $300,000-$375,000 in San Diego.  The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. 

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.