📜 Lead Regulatory Excellence as Senior Regulatory Affairs Specialist - South Korea
Join ICON plc in South Korea as a Senior Regulatory Affairs Specialist and become the driving force behind successful product registrations and regulatory compliance. This office-based senior role offers the opportunity to shape regulatory strategy, build key authority relationships, and ensure the timely approval of innovative treatments that benefit patients across South Korea.
🎯 Your Impact: Key Responsibilities
Strategic Regulatory Leadership
- Achieve timely and successful product registration in alignment with corporate and local regulatory strategies
- Design and assess comprehensive local regulatory plans, including new strategic concepts and license opportunities
- Develop local registration strategies that balance business objectives with South Korean regulatory requirements
- Provide expert regulatory input in cross-functional team meetings to guide development decisions
Regulatory Submission Excellence
- Manage all regulatory tasks and projects for assigned portfolio, including product and operations licenses
- Prepare and submit high-quality regulatory applications, ensuring timely approval from South Korean health authorities
- Monitor submission progress and coordinate strategic responses to health authority inquiries
- Ensure compliance with Corporate Policies, Regulations & Procedures, including CCDS implementation
Regulatory Intelligence & Authority Engagement
- Collect and analyze new or updated South Korean regulations through multiple intelligence sources
- Maintain close relationships with MFDS and other health authorities to facilitate effective regulatory interactions
- Communicate with regulatory authorities and industry groups on critical regulatory issues
- Conduct timely regulatory impact assessments for new guidelines and requirements
Cross-Functional Collaboration
- Provide expert regulatory consultation to local business stakeholders across multiple functions
- Participate in promotional material approval processes to ensure regulatory compliance
- Contribute to global regulatory initiatives and provide valuable local market insights
- Support clinical trial activities through management of regulatory submissions
Quality & Compliance Management
- Ensure timely submission of CCPS, CRC, Renewals, PSUR and other local validations
- Maintain accurate regulatory databases reflecting current registration status and requirements
- Oversee regulatory review timelines in e-MLR process for promotional materials
- Support audit readiness and contribute to CAPA processes as needed
⭐ Your Profile: Qualifications & Experience
Regulatory Expertise
- Extensive experience in South Korean regulatory affairs with proven track record of successful submissions
- Comprehensive knowledge of MFDS regulations, guidelines, and submission requirements
- Experience with product registration processes and clinical trial applications in South Korea
- Understanding of local regulatory landscape and industry practices
Strategic Capabilities
- Ability to develop and execute strategic regulatory plans aligned with business objectives
- Experience in regulatory intelligence gathering and impact assessment
- Strong analytical skills for evaluating regulatory requirements and opportunities
- Proven ability to navigate complex regulatory challenges
Relationship Management
- Established relationships with South Korean health authorities and regulatory stakeholders
- Excellent communication skills for effective authority interactions and cross-functional collaboration
- Experience working with industry groups and regulatory networks
- Ability to represent company interests in regulatory discussions
Technical Competencies
- Proficiency in regulatory documentation and submission processes
- Experience with regulatory databases and tracking systems
- Knowledge of clinical trial regulations and requirements in South Korea
- Understanding of promotional material compliance and review processes
💫 Why Join ICON in South Korea?
Strategic Impact
- Play a pivotal role in bringing innovative treatments to South Korean patients
- Shape regulatory strategy for product registrations and market access
- Build and maintain critical relationships with South Korean health authorities
- Influence regulatory processes and contribute to industry standards
Professional Growth
- Senior role with significant responsibility and strategic influence
- Clear pathway to Regulatory Affairs leadership positions
- Exposure to diverse therapeutic areas and complex regulatory challenges
- Opportunities for global collaboration and knowledge sharing
Office-Based Advantages
- Professional workplace environment with modern facilities
- Direct collaboration with local and international team members
- Access to comprehensive regulatory resources and tools
- Structured work environment with professional development support
Competitive Korea Benefits
- Attractive senior-level salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with 24/7 support
- Generous annual leave with Korean public holidays
Regulatory Leadership
- Retirement planning through Korean pension benefits
- Life assurance coverage
- Professional development and certification support
- Health and wellness programs
- Transportation and commuter benefits
✨ Ready to Lead Regulatory Success in South Korea?
If you're an experienced regulatory affairs professional with deep knowledge of South Korean regulations and proven submission expertise, we encourage you to apply. This senior office-based role offers the opportunity to drive regulatory strategy while ensuring compliance and successful product registrations that make a difference in patients' lives.
Apply Now & Lead Our Regulatory Excellence in Korea!
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ICON is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
We welcome applications from all qualified regulatory affairs professionals across South Korea - your regulatory expertise and authority relationships might be exactly what we need at ICON!
