RA Specialist (Contractor)
THE POSITION
- RA Specialist (Contractor)
- Employment Type: 1-year full-time contract
(Contract may be extended up to 10 additional months based on performance evaluation) - Department: Medicine Department / Regulatory Affairs Team
- Location: Seoul, Korea
Tasks & responsibilities
RA activities support for the below tasks
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 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