Parexel
Healthcare Insurance • Biotechnology • Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Senior Regulatory Affairs Associate, CMC
November 8
🗣️🇰🇷 Korean Required
Parexel
Healthcare Insurance • Biotechnology • Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
📋 Description
• 초기 단계 프로그램 및 상장 제품에 대한 CMC 전략 개발 • 규제 제출의 작성 및 검토 • 제조 변경의 규제 평가 수행 • 프로젝트 팀 회의에서 Regulatory CMC를 대변 • 전반적인 CMC 규제 정책 및 절차 개발에 기여
🎯 Requirements
• 제약 과학, 화학, 화학 공학 또는 관련 분야의 고급 학위(최소 석사 이상) • 규제 업무에서 최소 8년 이상의 경험 • 글로벌 CMC 규제 요구 사항 및 제출 프로세스에 대한 광범위한 지식 • 성공적인 규제 제출 및 보건 당국과의 상호작용 경력 • 제약 개발, 제조 공정 및 품질 시스템에 대한 강한 이해 • 소형 분자 및 생물학적 제제 모두에 대한 경험이 매우 바람직함 • 여러 프로젝트를 동시에 관리할 수 있는 뛰어난 프로젝트 관리 능력 • 강력한 분석적이고 문제 해결 능력 • 탁월한 서면 및 구술 의사소통 능력
🏖️ Benefits
• 유연 근무 옵션 • 글로벌 팀이 지원하는 직무 • 전문가와 함께하는 멘토링 기회
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