CG Oncology

Manager, Regulatory Affairs – CMC, Clinical

CG Oncology

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $125,000 - $145,000 per year

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategiesdocument preparationregulatory submissionsCMCclinical regulatory requirementseCTD structureregulatory documentation standardsIND-stage experienceclinical development programsrisk mitigation strategies
Soft Skills
cross-functional coordinationcommunicationcollaborationproblem-solvingattention to detailorganizational skillsinterpersonal skillsproject managementstrategic thinkingadaptability