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ORIC Pharmaceuticals Inc. · 2 days ago

Senior Vice President/Vice President, Regulatory Affairs

San Diego, CA

Full-time

Onsite

Director/Executive

$300K/yr - $425K/yr

15+ years exp

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by overcoming resistance in cancer. The Senior Vice President/Vice President, Regulatory Affairs, is responsible for developing and executing global regulatory strategies and overseeing the company's development pipeline from preclinical through commercialization.

BiopharmaBiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

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

Qualification

Regulatory AffairsOncology ExperienceRegulatory SubmissionsFDA InteractionsElectronic FilingsStrategic PlanningLeadershipTeam Mentoring

Required

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)