Regulatory Affairs Specialist, Seoul, South Korea
You will have the opportunity to work in a dynamic environment driven by innovation and continuous improvement. This role is ideal if you seek a workplace where diversity is valued, and employees are empowered to reach their full potential, perform at their best, and contribute to saving lives.
You will partner with a global pharmaceutical client that creates value through innovation, with the goal of improving health and lives for humans and animals alike.
What you will be doing:
* Achieve timely and successful product registration in line with corporate and local strategies.
* Gather and share information on new regulations and guidelines with the local RA team.
* Ensure compliance with company regulatory policies, regulations, and procedures.
* Design and assess local regulatory plans, including new strategies and license opportunities, and contribute to cross-functional team meetings.
Regulatory Planning and Submission
* Manage regulatory tasks and projects, including obtaining and maintaining product and operation licenses as required by local regulations.
* Prepare and submit regulatory applications, ensuring timely approval.
* Develop local registration plans aligned with business and global regulatory strategies.
* Monitor submission progress and coordinate responses to health authority inquiries.
* Comply with internal policies, including CCDS, CRC, and change control procedures.
* Support regulatory submissions for clinical trial activities.
Regulatory Intelligence and Interaction
* Collect and inform the team about new or updated local regulations.
* Conduct regulatory impact assessments promptly.
* Maintain relationships with health authorities and stakeholders for effective collaboration.
* Communicate with regulatory authorities and industry groups on regulatory issues.
Cross-functional Collaboration and Support
* Provide regulatory consultation and collaborate with local stakeholders.
* Participate in promotional material approval processes to ensure regulatory compliance.
* Contribute to global initiatives as needed.
Quality and Compliance
* Ensure timely submission of CCPS, CRC, renewals, PSUR, and other documentation.
* Keep regulatory databases updated.
* Meet timelines for regulatory reviews and ensure promotional materials comply with regulations.
* Support audits, CAPA, and inspection readiness.
* Archive regulatory submission documents appropriately.
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You are:
* Degree in Pharmacy preferred.
* Over 3 years of experience in the pharmaceutical, medical device, or health industry.
* Experience in regulatory affairs or related discipline preferred.
* Solid understanding of drug development.
* Good knowledge of national drug regulations and procedures.
* Proficient in English.
* Excellent communication skills for external and internal interactions.
* Good computer literacy, comfortable with databases.
* Experience in GMP documentation evaluation is a plus.
What ICON can offer you:
Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:
* Annual leave entitlements
* Health insurance options
* Retirement planning
* Global Employee Assistance Programme
* Life assurance
* Optional benefits like childcare vouchers, gym discounts, and more
Visit our careers website for more: https://careers.iconplc.com/benefits
At ICON, inclusion and belonging are core values. We are committed to providing an accessible, discrimination-free workplace. If you need accommodations during the application process, please let us know: https://careers.iconplc.com/reasonable-accommodations
If you're interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we're looking for
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