Director of Regulatory Operations - CG ONCOLOGY INC

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role:  Director of Regulatory Operations

Location: Remote US-Based

Essential Functions:

• Provide submission planning, preparation and publishing for electronic application and maintenance submissions to domestic and foreign regulatory agencies.
• Oversee technical aspects for submissions (e.g., eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities).
• Adept with publishing tool software such as InSight, ISIPublisher, eCTDXPress, Lorenz DocuBridge Publishing Software or similar.
• Provide leadership and direction of the Regulatory Operations function, including management of publishing vendors.
• Manages assigned projects and closely collaborates with personnel from Regulatory, Clinical, CMC, and other departments at CG Oncology (as with vendors), to coordinate and implement high quality submission outputs.
• Provide regulatory expertise and interpretation of submission requirements and technical guidance to team members and serve as representative to regulatory agencies on technical aspects of eCTD filings.
• Accountable for the management of submission projects, including the preplanning, tracking, assembly, submission, and archiving of regulatory documents.
• Serve as system owner for regulatory information tools and systems (e.g., eCTD publishing tools, electronic document management system [EDMS], library system, and electronic templates).
• Managing all communications, planning, and other activities with a third-party publishing organization.
• Maintain the submission-tracking process in support of short and long-term submission and resource planning.
• Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Work Flows for the Regulatory Operations function; ensure that CG Oncology practices are in conformance with the latest health authority and industry submission standards.
• Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.
• Works in a team environment comprising of clinical operations, regulatory, technical operations, quality, and clinical research organizations.
• Maintains version control of essential controlled clinical study documents (e.g., Study Protocols, Investigator Brochures [IBs], Informed Consent Documents [ICFs], Investigational Medicinal Product Dossiers [IMPDs], and Development Safety Update Reports [DSURs]).
• Reviews documents to ensure compliance with regulatory submission requirements and consistency of messages across all documents for drug development program(s).
• Identify appropriate resources/business strategies needed to support submission publishing activities, including but not limited to research of improved electronic document management systems and/or publishing tools.
• Actively contributes to best practices and continuous improvement within the Regulatory Department.

Qualifications:

• Bachelor’s Degree in relevant/scientific field or experience may substitute for minimum educational requirements.
• Ten (10) years of progressive managerial and regulatory operations experience at a high-growth pharmaceutical / biotechnology company, experience in therapeutic area in complex field (e.g. oncology, virology, etc.).
• 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.
• Demonstrated experience and a clear understanding of submission content and format requirements.
• Familiarity with interpretation of applicable FDA, ex-US, and ICH guidelines related to clinical trial and marketing application.
• Ability to travel to visit external vendors/partners and attend relevant conferences or meetings within and outside of the United States.

The U.S. target annual salary range for this remote, full-time, position is currently set at $205,000-$220,000. The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role.

Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES   
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to the meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS – We observe 12 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – PPOs & HDHP – Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.

  Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.