CG Oncology
11 - 50 employees
Founded 2010
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $120M Series E on 2022-11
Biotechnology • Healthcare Insurance • Pharmaceuticals
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.
Manager, Regulatory Affairs – CMC, Clinical
🕒 March 5
📊 Check your resume score for this job
Improve your chances of getting an interview by checking your resume score before you apply.
CG Oncology
11 - 50 employees
Founded 2010
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $120M Series E on 2022-11
Biotechnology • Healthcare Insurance • Pharmaceuticals
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.
📋 Description
• Support the development and execution of regulatory strategies for assigned programs. • Serve as a key regulatory contributor on cross-functional project teams. • Support interactions with U.S. and global health authorities. • Emphasize hands-on regulatory execution, document preparation, and cross-functional coordination. • Identify and communicate regulatory considerations, risks, and mitigation strategies. • Draft, review, and coordinate regulatory documents for submissions. • Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management. • Act as a regulatory representative on project teams, working closely with Clinical Development and other departments.
🎯 Requirements
• Bachelor’s degree in a scientific or related discipline. • Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development. • Demonstrated experience supporting IND-stage and/or clinical development programs. • Experience drafting regulatory documents and supporting regulatory submissions. • Working knowledge of CMC and clinical regulatory requirements. • Familiarity with eCTD structure and regulatory documentation standards.
🏖️ Benefits
• HIGHLY COMPETITIVE SALARIES • ANNUAL PERFORMANCE/MERIT REVIEWS • ANNUAL PERFORMANCE BONUSES • EQUITY • SPECIAL RECOGNITION • FULLY REMOTE WORK ENVIRONMENT • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off • HOLIDAYS –In 2025 we will observe 14 holidays • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary • HEALTH (MEDICAL, DENTAL, VISION) – PPO & 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
Apply NowSimilar Jobs
🕒 March 4
Manager of Compliance & Delegate Oversight responsible for analytics and reporting in healthcare context. Overseeing performance monitoring frameworks and ensuring regulatory compliance across operations.
🇺🇸 United States – Remote
💵 $130.3k - $195.5k / year
💰 $135M Series C on 2020-03
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
🕒 March 4
IT FIPS Compliance Lead at Accenture Federal Services ensuring compliance with FIPS standards. Leading security assessments and collaborating with cross-functional teams to address vulnerabilities in the organization.
🕒 March 4
Policy and Compliance Lead at Danaher developing and implementing information security policies and standards. Leading compliance initiatives while collaborating with cross-functional teams.
🕒 February 28
Associate Director in Regulatory Affairs for pharmaceutical company developing therapies for endocrine disorders. Responsible for regulatory strategy implementation and submissions throughout development and commercialization.
🕒 February 26
Security and Compliance Engineer at Sully.ai focused on identifying security risks and building compliance programs. Driving efficiency and initiatives in a remote work environment.
