Lead Regulatory Strategy from South Korea
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are seeking an experienced Manager, Regulatory Affairs based in South Korea to provide strategic regulatory leadership for our drug development programs. In this pivotal remote role, you will independently lead regulatory activities and submissions, guide internal teams, and interact with health authorities to navigate the complex regulatory landscape from early development through to post-approval.
Your Role: Strategic Leadership & Execution
You will be a key contributor to the regulatory strategy and operational success of assigned projects, leveraging your deep expertise to ensure compliance and facilitate timely approvals.
Key Responsibilities:
- Lead Regulatory Submissions: Independently manage and lead the preparation, submission, and lifecycle management of key regulatory filings including Clinical Trial Applications (CTA), Investigational New Drug (IND) applications, and Marketing Authorization Applications (MAA) in South Korea and other regions as required.
- Provide Strategic Guidance: Serve as the regulatory expert, providing strategic guidance and operational support to cross-functional project teams throughout the drug development lifecycle.
- Health Authority Interaction: Represent ICON and our sponsors in interactions with regulatory agencies (including MFDS), preparing for meetings and managing queries.
- Regulatory Intelligence & Best Practices: Maintain a strong understanding of global and local (South Korea) regulatory requirements. Contribute to the development of best practices within ICON's Regulatory Affairs function.
- Team Leadership & Collaboration: Lead internal regulatory teams on projects and collaborate effectively within cross-functional teams to drive project success.
Your Profile: Qualifications & Experience
Education & Experience:
- Bachelor's degree in Pharmacy, Life Sciences, Medicine, or a related healthcare/scientific field. An advanced degree (Master's, PhD) is preferred.
- A minimum of 6 years of direct, hands-on experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Proven track record of independently leading regulatory submissions (CTA/IND/MAA) in South Korea. Experience with other APAC or global submissions is highly advantageous.
- Strong, practical knowledge of MFDS regulations, ICH guidelines, and global regulatory requirements.
Key Competencies:
- Strategic thinker with excellent problem-solving and decision-making abilities.
- Strong leadership skills with the ability to guide teams and manage projects independently.
- Exceptional communication and interpersonal skills, with fluency in Korean and English.
- Proactive, detail-oriented, and able to thrive in a dynamic, remote work environment.
Why Join ICON?
Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.
We Offer a Competitive Benefits Package:
- Very competitive salary and performance-driven annual bonus.
- Comprehensive health insurance for you and your family.
- Competitive retirement plans and life assurance.
- Global Employee Assistance Programme providing 24/7 wellbeing support.
- Generous annual leave and flexible benefits.
Our Commitment to You:
At ICON, inclusion and belonging are fundamental. We are proud to be an equal opportunity employer dedicated to providing an inclusive and accessible environment for all candidates.
Ready to lead regulatory strategy for innovative therapies from your home base in South Korea?
Apply now for the Manager, Regulatory Affairs position.
We encourage all qualified candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
