(Senior) Regulatory Affairs Specialist

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

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.

As a Senior Regulatory Affairs Specialist at ICON, you will ensure regulatory compliance and facilitate the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.

What You Will Do:

Responsibilities:

• To achieve timely & successful product registration in accordance with corporate & local strategies
• To collect any information on new regulations and guidelines and the share it in local RA team
• to ensure compliance with company regulatory policies, regulations and procedures
• Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting

Regulatory Planning and Submission

• Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company 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 submission & coordinate timely responses to all questions from the health authorities
• Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee(CRC) and local change control procedures
• Management of regulatory submissions to support clinical trial activities

Regulatory Intelligence and Interaction

• Responsible to collect new or updated local regulations via various potential sources and keep the local RA team informed
• Ensure a regulatory impact assessment in timely manner
• Close relationships with relevant health authorities and other organizations / key stakeholders to facilitate and develop effective collaboration on regulatory interactions
• Communicate with Regulatory Authorities and local industry groups on regulatory issues

Cross-functional collaboration and support

• Provide regulatory consultation & collaborate with local business stakeholders
• Participates in the promotional material approval process in order to ensure regulatory compliance regarding these promotional material s and activities
• Provide feedback to global and participate in global initiatives when requires

Quality and Compliance

• Timely submission of CCPS, CRC, Renewals, PSUR and other local validation in compliance with internal KPIs
• Ensures that regulatory database is up to date to reflect the current registration status or regulatory requirements
• Ensure that timelines for regulatory review in the e-MLR process are met and promotional materials comply with local regulations
• Contribute to audits, CAPA process as appropriate and support local inspection readiness
• Archiving of local regulatory submission Documents

Qualification and Requirements:

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

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply