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RA Specialist (Contractor)

THE POSITION

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

 

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 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

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