RA Associate (1~3 year Pharmaceutical Regulatory Affairs working experienced)
AMinimum of a Bachelor's degree in a pharmaceutical is required.
1~3years of working experience within the pharmaceutical regulatory environment.
Pharmacist license is mandatory.
Expert knowledge, understanding andapplication of principles, concepts and practices of government regulations arerequired.
Strong communication, organizational,negotiation and interpersonal skills are required.
Strong verbal and written communication skillsin English & Korean.
-Prepare submissions for the new product registration.
-Maintain a close working relationship with regulatory authorities (MFDS, NIFDS)for the product registration.
-Initiate, track and facilitate new product registrations in Korea and achieveon-time approvals
-Maintain regulatory compliance of registered products under Korean regulation.
-Proactively renew licenses to avoid business interruptions
-Coordinate documents compiling and perform all regulatory assessments for GCC (GlobalChange Control) with Regional/Global RA.
-Monitor regulatory environment changes, and provide impact analysis plusaction plans to ensure compliance
-Interaction with local regulatory authorities, experts, and industrygroups to drive new guidelines / regulation toward harmonized internationalstandards
-Communicate local environment change and registration status to local,regional, and global stakeholders
|제출서류||국문이력서(구체적인 경력기술 포함)|