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워싱턴 DC 인근에 위치한 한국 유망 제약 회사에서는 RA 분야에서 근무할 인재를 구하고 있습니다.

Job Title: Regulatory Affair
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.

Key Responsibilities
• 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.

Qualifications
• 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).

What We Offer
•     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.

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