RA Specialist

Description

• 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

Qualifications

• RA experience in pharmaceutical industry for more than 3 years (Preferably RA experience from multinational pharmaceutical companies for drug registrations for chemical / 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
• Fluent in Korean
• Good organizational and communication skills, active and diligent attitude
• Fluent English skill in 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
• No restrictions for international travel