Senior Regulatory Affairs Specialist

Home-Based, Seoul, South Korea

As a (Sr. Regulatory Affaris Specislit) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Prepare, submit and support clinical trial applications in Korea and South East Asia countries

• Prepare, submit and support Import License applications for medical devices in Korea and South East Asia countries

• Collaborate and communicate effectively with teams internally and external bodies to meet business objectives related with clinical trials

  Maintain current knowledge of relevant regulations, including proposed and final regulations and provides regulatory affairs related information to other divisions and departments

• Develop and maintain standard operating procedures or local working practices

• Formulated and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained

• Assist Regulatory Country Head to manage activities such as audits, regulatory agency inspections, or product recalls

#LI-remote

#LI-SO1

You are:

• Computer Sills: Experience in working with MS Office in a Windows environment

• Negotiating, communication and interpersonal skills

• Fluency in written and spoken English

• BS in Pharmacy or Life Scineces
• +2 yrs IND submission experience in CRO or Pharmaceutical Industry
• Home-Based

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.