RA Specialist (Contractor) 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.
Contract will be ended in September 2027
- 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 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
- Learning agility
