RA Specialist is responsible for preparing and submitting regulatory documents, maintaining product compliance, and liaising with regulatory authorities to support product approval and lifecycle management ensuring that a company's products comply with all relevant regulations and guidelines throughout their lifecycle.

• Product Registration & Registration Maintenance - Achieve timely & successful product registrations in accordance with corporate & local strategies - Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses on behalf of BI as required by local regulations - Compile registration applications for new products and variations to marketed products - Monitor progress of submissions & coordinate timely responses to all questions from the Regulatory Authorities. - Be Compliant with Corporate policies, principles & procedures, in particular implementation of current Company Core Data Sheet (CCDS), Chain Review Committee (CRC) and local change control procedures. • Regulatory Intelligence - Collect any information on new Regulations and Guidelines, and to share it in local RA team - Be responsible to collect the up-to-date information on local regulation via internet searching & communication with colleagues in other pharmaceutical companies • Business support - Provide regulatory consultation & collaborate with local business partners (e.g., Medical Affairs, Market access, PM/Sales and etc)) • Compliance - Ensure compliance with Company regulatory policies, principles & procedures - Ensure that regulatory database is up to date to reflect the current registration status or regulatory requirements (e.g., CPD3, RequireBASE or other information sources) • Regulatory interaction - Communicate with Regulatory Authorities and local industry groups on regulatory issues

• RA experience in pharmaceutical industry for more than 3 years (Preferably more than 5 years RA experience of drug registrations for oncologic / biologic pharmaceutical products and/or for rare disease treatment) • Bachelor’s degree in pharmacy and/or Professional Training • Knowledge of local and international regulatory affairs regulation • Good organizational and communication skills, active and diligent attitude • Fluent in Korean and English (reading/writing/speaking) • Knowledge & Insight in the local pharmaceutical regulation & industry • Ability and confidence to communicate professionally with Regulatory Authorities and other external and internal people • Learning agility

For more details, please refer to the company website.