DIRECTOR OF REGULATORY OPERATIONS
Company: Cg Oncology, Inc.
Location: Irvine
Posted on: September 29, 2024
Job Description:
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.
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.
Keywords: Cg Oncology, Inc., Irvine , DIRECTOR OF REGULATORY OPERATIONS, Executive , Irvine, California
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