Regulatory Affairs Specialist, Office-Based (South Korea)
Your Mission: Be the Expert Navigator of South Korea’s Regulatory Pathway
At ICON in South Korea, our mission to advance clinical development relies on precise and proactive regulatory strategy. As a Regulatory Affairs Specialist, you will be the crucial expert ensuring our clinical trials and product submissions comply fully with the Ministry of Food and Drug Safety (MFDS) regulations. This office-based role is central to our success, where you will manage critical submissions, maintain product licenses, and act as the key liaison between global teams and the local regulatory authority. If you are a detail-oriented professional with a strong grasp of Korean pharmaceutical regulations and a passion for bringing new therapies to patients, this is your opportunity to build a meaningful career at the heart of clinical research.
We are looking for a skilled regulatory professional to manage the end-to-end regulatory lifecycle for clinical trials and marketed products. Your expertise will ensure smooth operations and compliance, from initial application to post-approval maintenance.
Your Impact: Manage Core Regulatory Submissions & Compliance
You will be responsible for a range of essential regulatory activities, serving as the local expert who navigates the complexities of the South Korean regulatory landscape.
1. Lead Clinical Trial & Product Registration Submissions
- Prepare and submit all documentation required for clinical trial applications (CTAs) to the MFDS, ensuring alignment with global strategy and local requirements.
- Manage the registration and maintenance of Site Master Files (SMF) for foreign manufacturing sites and Drug Master Files (DMF) for active pharmaceutical ingredients.
- Handle Over-the-Counter (OTC) product notifications and manage the submission of safety data, foreign usage reports, quality documents, labeling materials, import records, and license renewals.
2. Ensure Ongoing Regulatory Compliance & Maintenance
- Maintain up-to-date knowledge of evolving MFDS regulations, guidelines, and submission requirements, proactively advising internal teams on necessary actions.
- Manage the lifecycle of regulatory approvals, including variations, renewals, and annual reports, ensuring all products remain in full compliance.
- Serve as the primary point of contact for the MFDS, managing queries, communications, and inspections with professionalism and expertise.
3. Collaborate & Support Cross-Functional Teams
- Work closely with global regulatory, clinical, and quality assurance teams to compile accurate and timely submission packages.
- Provide regulatory intelligence and strategic input during project planning to identify potential hurdles and ensure efficient pathways to approval.
- Ensure all regulatory activities are documented accurately and archived properly for audit readiness.
Who You Are: A Meticulous Regulatory Professional
You are a proactive and organized individual with a solid foundation in South Korean regulatory affairs. You are a strong communicator who thrives in a collaborative, fast-paced environment and is committed to the highest standards of accuracy and compliance.
Your Foundation
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related scientific field.
- Proven experience in Regulatory Affairs within the pharmaceutical, biotechnology, or CRO industry in South Korea.
- In-depth, practical knowledge of MFDS regulations, submission processes, and requirements for clinical trials and product registrations.
- Full professional proficiency in Korean and English (both written and verbal) is essential for managing local submissions and global communications.
- Excellent organizational skills and meticulous attention to detail.
Your Core Strengths
- Expert Implementer: You have hands-on experience preparing and managing MFDS submissions (CTAs, DMF, SMF, OTC notifications) from start to finish.
- Proactive & Collaborative: You take initiative, anticipate needs, and work effectively with both local and international colleagues to achieve common goals.
- Effective Communicator: You can explain complex regulatory requirements clearly and build professional relationships with internal stakeholders and health authorities.
- Adaptable Learner: You thrive in a dynamic setting, can manage multiple priorities, and are eager to stay updated on the changing regulatory landscape.
- Quality-Focused: You understand that precision in documentation and process is non-negotiable in regulatory work.
Why Build Your Regulatory Career at ICON in South Korea?
Master Local Regulations with a Global Outlook
- Office-Based Collaboration: Join our dedicated South Korean team in a professional office environment where you can collaborate closely and grow your expertise.
- End-to-End Exposure: Gain valuable experience across the full regulatory spectrum, from clinical trials to post-marketing compliance, within a leading global CRO.
- Strategic Impact: Play a key role in enabling innovative clinical research and ensuring patient access to new treatments in the South Korean market.
Grow with a Supportive, Global Leader
- Benefit from ICON’s vast global resources, training programs, and network of regulatory experts.
- Develop a rewarding career path with opportunities for advancement within the global regulatory affairs function.
- Be part of an inclusive culture that values your contribution and is dedicated to shaping the future of clinical development.
Competitive ICON Benefits in South Korea
- We offer a competitive salary and benefits package.
- Enjoy comprehensive health insurance, generous annual leave, and support for your well-being and professional development.
