Alcon are one of Korea ‘Top Employer’s’ and are the market leader in eye care globally, helping people see better through advanced surgical and vision care products and if you want to help make a difference then please join us!
This role is responsible for new product registration and maintenance of existing product licenses within Korea and collaborating with global and Korea cross-functional business partners. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority products and programs.
§ Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products (Medical Devices, Drugs, and Quasi-drugs) in Korea, aligned with Global Regulatory and Region and Country business strategies and plans.
§ Ensure team and individual capability to lead and manage the assigned projects and initiatives: resource obtainment & allocation, team engagement, people development, process optimization, and continuous improvement.
§ Ensure regulatory compliance to secure business continuity – labelling, license variation, license renewal, KGMP certification, and Health Authority reporting in collaboration with relevant stakeholders
§ Strategic communication with the country's regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions.
§ Work with commercial colleagues to develop promotional strategies and provide regulatory review for promotional materials.
§ Shape regulatory environment through active engagement to industry activity (KMDIA), Health Authority initiatives, and Health Authority education programs.
§ Monitor and provide regulatory intelligence on new medical device legislation, guidance, and policy proposals impacting Alcon’s products or processes. Provide regulatory intelligence on competitive products and companies.
§ Comply with all legal, regulatory, and ethical business requirements in executing the assigned roles and responsibilities as defined in the local regulation and the Corporate procedure
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Employees
Find Jobs for Contingent Worker
Eligibility Requirements
No reason for disqualification on overseas business trip
Men are required or exempted from military service.
Information on returning employment documents
* All applicants, except those who pass the final round, will be able to claim the return of the submitted employment documents during the period between 14 and 180 days from the date on which employment is confirmed.
*In preparation for the applicant's request for return, we will keep the documents within 180 days after the announcement date of the final successful candidate, and the documents that have expired return period will be destroyed under the Personal Information Protection Act.
-If the application is submitted on the website or by e-mail, or if the applicant submits it voluntarily without our request, it shall not be returned in accordance with the proviso to Article 11 (1) of the Fairness of the Employment Procedure Act, and if the employment documents are destroyed due to natural disasters or other reasons not liable to us, it shall be deemed to have been returned.
*Applicants who wish to request the return of employment documents under the proviso to paragraph (1) submit a return request (Form 3 of the Enforcement Rules of the Act on the Fairness of Employment Procedures) by e-mail to the person in charge of employment and we send it to the designated address within 14 days from the date the submission is confirmed.