Director, Regulatory Affairs - CMC
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, REGULATORY AFFAIRS – CMC
Location: Remote US-Based
- The Director of Regulatory Affairs - CMC will play a pivotal role in CG Oncology’s Regulatory Affairs strategy for Chemistry, Manufacturing, and Controls (CMC) activities related to our bladder cancer immunotherapy.
- This individual will lead regulatory initiatives, working closely with the Technical Operations and Quality teams to ensure compliance with all applicable regulations and standards while contributing to the successful commercialization of our product.
- They will be responsible for keeping up to date on the evolving global GTx landscape and regulations, serving as the Reg-CMC voice for the company’s immunotherapy products, writing CMC sections of submissions.
- Bachelor's degree in a relevant scientific discipline.
- Minimum of 10 years of experience in regulatory affairs with a strong focus on CMC for biopharmaceutical products.
- Proven experience with BLA submissions and commercialization activities.
- In-depth knowledge of global regulatory requirements, particularly those related to CMC.
- Strong project management skills with the ability to lead and prioritize tasks effectively.
- Excellent communication and interpersonal skills to engage with cross-functional teams and health authorities.
- Leadership and mentoring capabilities to guide and develop regulatory affairs professionals.
- Problem-solving and critical-thinking skills to address regulatory challenges effectively.
The U.S. target annual salary range for this remote, full-time, position is currently set at $200,000 - $215,000. 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.
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
- SPECIAL RECOGNITION
In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet most 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) – HMOs, PPOs & HDHP – Anthem/MetLife
- 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.