모집부문 : Regulatory Affair
주요업무
[Regulatory Affairs ] *Managing




Product registration of medicinal products and medical devices and life cycle management of product licenses
Manage regulatory projects related to South Korea including regulatory maintenance


Monitor policy changes and responsible to escalate these to local and global management team once any significant impact caused by the policy changes are foreseen


Maintain local RA SOPs to meet 0000 SOPs and local regulations.



[Pharmacovigilance] * Managing


Set up and maintain documentation system of PV (pharmacovigilance) in 0000 Office, make sure the system meets both local regulations and  0000 SOPs, and keep it up-to-date in timely manner to reflect the changes of circumstances
Directly communicate with HQ to keep up-to-date all PV relevant contracts (between 0000 Diagnostics Inc. and 0000 Korea) related to South Korea and make sure that all contract parties comply with the contract requirements


Prepare and attend the internal GVP audit by CQM and follow up CAPAs


Submit relevant drug safety reports to the local health authority within timeline if these are required by the local regulations.



[Clinical Study Management]


Local management of Investigator Initiated Studies including, proposal submission, and research agreement management
Operate local clinical studies performed in South Korea


Prepare and attend the audit whenever it is called for the studies performed in South Korea by local authorities.


Local CRO selection and management of their activities whenever required by project


Provide product information to the internal employees and external customers whenever requested according to the local and 0000 SOP


Review promotional materials according to the local and 0000 SOP



[Quality Assurance]


Be reported from QA Manager for local product release and management of imported products
Approve local batch release as QP of 000



       [P&R specialist]


price and reimbursement
[자격요건]




bachelor's degree in Pharmacy – 약사 필수

Fluent in English


Over 10 years’ experience in the pharmaceutical industry, including management of all different regulatory affairs processes.