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 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 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
