Home Job Postings 한국계 유망 제약 회사에서 Regulatory Affair 분야에서 근무 하실 분을 구합니다. This topic has replies, 0 voices, and was last updated 11 hours ago by Job Guide USA. Now Editing “한국계 유망 제약 회사에서 Regulatory Affair 분야에서 근무 하실 분을 구합니다.” Name * Password * Email Topic Title (Maximum Length 80) Company * Location Expires at 안녕하세요. 워싱턴 DC 인근에 위치한 한국 유망 제약 회사에서는 RA 분야에서 근무할 인재를 구하고 있습니다. <strong>Job Title: Regulatory Affair </strong> We are looking for a proactive Regulatory Affair to manage regulatory safety compliance for our Phase I clinical trials. In this role, you will provide critical support for our Phase I clinical trials, acting as a liaison between the company and our CROs. <strong>Key Responsibilities</strong> • Regulatory & Safety Liaison: Serve as the functional point of contact between the company and the CRO for all regulatory safety matters. Facilitate clear and consistent communication to ensure project goals are met. • Submission Coordination: Collaborate with the CRO to coordinate the preparation and review of safety-related dossiers, such as IND Safety Reports, SUSARs, and DSURs, ensuring they reflect the company’s internal clinical insights before submission. • Safety Information Management: Act as a bridge between the Clinical Operations and Pharmacovigilance teams to ensure that safety signals from Phase I dose-escalation cohorts are accurately relayed to and processed by the CRO. • Document Alignment: Partner with the CRO in the drafting and refinement of essential documents, including Clinical Study Protocols, Investigator’s Brochures (IB), and Informed Consent Forms (ICF), ensuring regulatory consistency. • Compliance Facilitation: Support the CRO in adhering to ICH-GCP and FDA guidelines by providing necessary sponsor-level guidance and performing periodic reviews of the regulatory archives and safety data. <strong> Qualifications</strong> • Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field. • Experience: 1–3 years of experience in Regulatory Affairs or Clinical Operations or experience in a professional office setting, preferably within the biotech, pharmaceutical, or healthcare industry. • Fundamental understanding of the CRO-Sponsor relationship and oversight processes. • Knowledge of Phase I safety reporting requirements and clinical trial regulations (FDA 21 CFR, ICH-GCP). <strong>What We Offer</strong> • Competitive compensation • Comprehensive Health, Dental, and Vision Insurance • Paid Time Off (PTO): Vacation, Sick, and Personal leaves • Opportunities for growth in a rapidly evolving company • The chance to be part of a company dedicated to a meaningful scientific mission. 이력서 지원 이메일 주소 : HR@jobguideusa.com 감사 합니다. I agree to the terms of service Update List
