ORIC Pharmaceuticals, Inc. Careers

Description

• Manage the preparation, coordination, and submission of regulatory documents for investigational drug development and drug marketing applications across global markets (including INDs, NDAs, MAAs, and associated amendments/updates)
• Perform high quality and timely regulatory submissions to regulatory agencies such as FDA, EMA, Health Canada, and other international authorities in alignment with regulatory/corporate goals
• Maintain a thorough understanding of regulatory requirements for drug applications in key markets, ensuring compliance with applicable regulations (eg, 21 CFR, ICH, EU guidelines)
• Ensure appropriate review and approval of regulatory submission output according to established workflow, including annual reports, periodic safety reports, and expedited safety reports, as necessary
• Perform submission publishing in eCTD tool and submit to regulatory agencies as required (eg, FDA Electronic Submission Gateway [ESG])
• Perform regulatory operations tracking of submission (US and ex-US), agency correspondence, nonclinical reports, protocol number/clinical trial assignment and other regulatory operations activities as identified. Ensure proper documentation, archiving, and tracking of all regulatory submission materials and correspondence, ensuring accessibility and compliance with record retention policies.
• Oversee and support the maintenance and continuous improvement of regulatory operations systems, tools, and templates
• Refine regulatory submission processes to improve efficiency and compliance, ensuring that systems are in place to track submissions, approvals, and status updates. Support regulatory operations in due diligence activities as required
• Develop and implement standard operating procedures (SOPs) for regulatory operations and ensure compliance with company policies and global regulatory standards. Support initiatives for process improvements and best practices within the Regulatory Operations team.
• Work closely with Regulatory Affairs, Clinical, Nonclinical, Quality Assurance, and Manufacturing teams to gather necessary documentation and ensure alignment on submission strategy.
• Act as a liaison between the regulatory team and other departments to ensure smooth communication and coordination of submission timelines and deliverables. Monitor regulatory submission status, providing timely updates to leadership and key stakeholders
• Stay up-to-date with evolving global regulatory requirements, guidelines, and industry trends that could impact regulatory submissions and approval timelines
• Support the review of regulatory agency queries and feedback promptly and effectively, ensuring that responses are comprehensive and in alignment with strategic goals.
• submission requirements, tools, and processes as required.

• BA/BS with science major, or an equivalent combination of education and related experience.
• 5-7 years of progressively responsible experience in a pharmaceutical or biotechnology company. Strong understanding of regulatory submission processes and electronic submission systems (eg, eCTD, CTIS, eSubmissions).
• Working knowledge of Federal Regulations including Part 11 regulations. Detail-oriented with a focus on accuracy and compliance.
• Excellent project management, organizational, and problem-solving skills with a proven ability to manage multiple projects and deadlines. Ability to work cross-functionally in a fast-paced, collaborative environment.
• Exceptional written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and regulatory submission management tools
• Effective team leadership and participation skills.