Regulatory Job at Precision Medicine Group, S Korea | Life Sciences | Apply Online
If you are an early-career clinical trials professional with a sharp instinct for international regulatory frameworks and site activation operations, this full-time position at Precision for Medicine is an outstanding opportunity. Located in Seoul, South Korea, this role integrates regulatory compliance with clinical site logistics to accelerate trial launch timelines. For organized coordinators searching for a high-impact Regulatory Job, this position provides a front-row seat to the complex world of Ministry of Food and Drug Safety (MFDS) and Institutional Review Board (IRB) filings. It serves as an elite launchpad for an enduring Precision Medicine Group career and stands out as a highly specialized Life Sciences Job in Asia’s booming biomedical sector.
- Job Position: Regulatory and Site Start-Up Specialist
- Location: Seoul, South Korea
About The Company
Precision for Medicine is a global, full-service clinical Contract Research Organization (CRO) dedicated to shifting the landscape of advanced therapeutic development. By integrating novel clinical trial designs, industry-leading medical experts, and sophisticated biomarker data analytics, the company accelerates the delivery of life-changing treatments. Precision is widely recognized for its deep focus on rare diseases and complex oncology pipelines. It fosters a collaborative workplace culture where individual contributions are valued, ideas are nurtured, and team members actively drive positive healthcare changes.
Regulatory Job – Key Responsibilities
As a Regulatory and Site Start Up Specialist, you are responsible for the timely and quality-driven delivery of site activation readiness within South Korea, actively predicting and mitigating clinical pipeline risks.
Your core submission, operational, and stakeholder management duties will include:
- Dossier Preparation & Submission: Drafting and compiling complete clinical trial application forms, amendments, and notifications for submission to Competent Authorities (such as the MFDS), Ethics Committees, and local IRBs in accordance with ICH-GCP rules.
- Agency & Board Liaison: Interacting directly with regulatory bodies and local IRBs to handle formal clarification responses, negotiate study parameters, and secure official trial approvals.
- Tracking & Milestone Management: Acting as the local Subject Matter Expert (SME) for critical path data points. You will update milestone tracking tools, regulatory intelligence databases, and project managers on submission timelines.
- Essential Document Governance: Customizing country-specific Patient Information Sheets (PIS) and Informed Consent Forms (ICFs). You will manage document translations and coordinate with site-based CRAs to review and collect the mandatory documentation required for Investigational Medicinal Product (IMP) drug release.
- Contracts & Outreach Support: Assisting the Site Contract Management department with local study budget negotiations and investigator contract execution, while occasionally supporting the feasibility team with investigator site outreach.
- Audit & Inspection Readiness: Maintaining absolute audit readiness at all times, ensuring all essential communications and regulatory certificates are filed precisely per the Trial Master File (TMF) study plan.
Qualifications & Profile Requirements For Regulatory Job
This intermediate start-up vacancy requires a blend of rigorous scientific training, clear data organization, and a strong baseline understanding of South Korea’s clinical trial laws.
- Required Criteria:
- Educational Foundation: A Bachelor’s degree in Life Sciences, or a related scientific discipline is required to secure this Life Sciences Job.
- Industry Track Record: Minimum of 1 year of experience working as a Regulatory Affairs or Site Start-Up Specialist (or a comparable operational tracking role) within a CRO, biotechnology company, or pharmaceutical industry setting.
- Linguistic & Software Skills: Absolute fluency in written and spoken English is mandatory. High proficiency utilizing computerized information systems, electronic spreadsheets (Excel), and milestone tracking tracking tools is required.
- Highly Beneficial & Preferred Assets:
- An active qualification in Pharmacy or direct professional work experience as a Registered Pharmacist.
- An advanced graduate degree in medical or life sciences (MD, PhD, PharmD) or a formal Master’s in Regulatory Science / RAC certification via RAPS.
- Proven experience in executing local feasibility studies, budget structures, and contract negotiation parameters within the South Korean healthcare system to advance your Precision Medicine Group career.
In short, the Regulatory and Site Start Up Specialist position at Precision for Medicine is a definitive route to transitioning your foundational clinical trials experience into a highly marketable, specialized regulatory portfolio. Securing this role allows you to step away from generic laboratory bench work or routine trial tracking to manage the critical path operations that determine how fast groundbreaking cancer therapies reach patients in need. If you live in or near Seoul, hold a life sciences degree, and possess at least a year of start-up tracking experience, apply today to secure this premier Regulatory Job.
