(Sr.)Regulatory Affairs Specialist-South Korea-ICON Strategic Solutions

Job title: (Sr.) Regulatory Affairs Specialist-South Korea-ICON Strategic Solutions

About the Role ICON is seeking a Senior Regulatory Affairs Specialist for South Korea to ensure regulatory compliance and support the timely registration and ongoing licensing for its portfolio. You will design local regulatory plans, manage submissions, monitor regulatory developments, and interact with health authorities as part of ICON Strategic Solutions.

What You'll Do

• Achieve timely and successful product registration in accordance with corporate and local strategies
• Collect information on new regulations and guidelines and share it with the local RA team
• Ensure compliance with company regulatory policies, regulations and procedures
• Design and assess local regulatory plans including new strategic concepts and license opportunities; provide consolidated input on key regulatory development in cross-functional team meetings
• Manage all regulatory tasks and projects, including attaining, maintaining product licenses and operations licenses for assigned portfolio as required by local regulations
• Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
• Develop local registration plans in alignment with local business and global regulatory strategy
• Monitor progress of submissions and coordinate timely responses to all questions from the health authorities
• Be compliant with Corporate Policies, Regulations & Procedures, including CCDS, CRC and local change control procedures
• Manage regulatory submissions to support clinical trial activities
• Regulatory Intelligence and Interaction: collect new or updated local regulations and keep the local RA team informed; perform regulatory impact assessments in a timely manner; maintain close relationships with health authorities and stakeholders to facilitate collaboration; communicate with regulatory authorities and local industry groups on regulatory issues
• Cross-functional collaboration and support: provide regulatory consultation and collaborate with local business stakeholders
• Participate in the promotional material approval process to ensure regulatory compliance and provide feedback to global initiatives when required
• Quality and Compliance: timely submission of CCPS, CRC, Renewals, PSUR and other local validations; keep regulatory databases up to date; ensure e-MLR review timelines and promotional materials comply with local regulations; contribute to audits and CAPA; support local inspection readiness; archiving of local regulatory submission documents

What We're Looking For

• Degree in Pharmacy preferred
• 3+ years of experience in pharmaceutical, medical device or health industry
• Experience in regulatory affairs or relevant discipline preferred
• Solid understanding of drug development
• Good knowledge of National Drug Regulations and Procedures
• English proficiency
• Good communication skills for external and internal interaction
• Good computer literacy, comfortable working with databases

Compensation & Benefits

• Various annual leave entitlements
• Health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings
• Global Employee Assistance Programme LifeWorks with 24-hour access to a global network of professionals
• Life assurance
• Flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, etc.)
• ICON is committed to inclusion and belonging and provides an accessible environment for all candidates