Regulatory Operations Director

4 weeks ago

Irvine, California, United States CG ONCOLOGY INC Full time
Join Our Team as a Regulatory Operations Director

Cg Oncology, Inc. is seeking a highly skilled Regulatory Operations Director to join our team. As a key member of our regulatory operations function, you will be responsible for providing strategic leadership and direction to ensure the successful planning, preparation, and publishing of electronic submissions to domestic and foreign regulatory agencies.

Key Responsibilities:
  • Submission Planning and Preparation: Develop and implement submission plans, ensuring timely and accurate submission of regulatory documents to domestic and foreign regulatory agencies.
  • Regulatory Operations Leadership: Provide strategic direction and leadership to the regulatory operations function, including management of publishing vendors and coordination with cross-functional teams.
  • Regulatory Expertise: Provide regulatory expertise and interpretation of submission requirements and technical guidance to team members and serve as a representative to regulatory agencies on technical aspects of eCTD filings.
  • Submission Tracking and Management: Maintain the submission-tracking process in support of short and long-term submission and resource planning.
  • System Ownership: Serve as system owner for regulatory information tools and systems, including eCTD publishing tools, electronic document management system (EDMS), library system, and electronic templates.
Requirements:
  • Education: Bachelor's degree in a relevant scientific field or equivalent experience.
  • Experience: Ten (10) years of progressive managerial and regulatory operations experience at a high-growth pharmaceutical/biotechnology company, with experience in a complex therapeutic area (e.g., oncology, virology, etc.).
  • Regulatory Knowledge: Demonstrated understanding and strategic application of submission regulations and guidelines for drug development at IND and NDA/BLA stages, including familiarity with international regulatory requirements and documentation.
  • Communication Skills: Excellent communication and leadership skills, with the ability to travel to visit external vendors/partners and attend relevant conferences or meetings within and outside of the United States.
What We Offer:
  • Competitive Salary: $205,000-$220,000 per year, depending on experience and qualifications.
  • Total Rewards Package: Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Opportunities for Growth: Career advancement opportunities within a dynamic and growing company.

Cg Oncology, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you are a motivated and experienced professional looking for a new challenge, please submit your application today.

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