**Tasks & responsibilities** + **_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_ **Requirements** + _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_ All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.