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Open Position

Open Position

외국계 제약사에서 RA Specialist(대리~과장)채용합니다.

  • 2021-08-11 14:16:00
  • 1.223.120.93

[Regulatory Strategy/Planning]

  • As assigned, gather, analyse and communicate internal and external regulatory intelligence
  • Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
  • Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with guidance from DRA Management
  • As assigned, represent Affiliate Regulatory in cross-functional teams

[Regulatory Filing]

  • Adapt global product dossiers to local requirements
  • Prepare and manage regulatory registration filings across product lifecycles: Communication with global for filing, submission & requirements(CPP, ToC, Bridging report, GMP inspection & documents, Sample)
  • Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
  • Ensure timely regulatory filings submissions and approvals
  • Influence internal and external stakeholders for successful regulatory outcomes

[Regulatory Compliance]

  • Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
  • Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities
  • Ensure regulatory compliance for product released to market according to marketing authorisations
  • Ensure that all the changes (CDS, TRIC) for responsible products are proceeded according to local SOP and avoid the non-compliance
  • Timely manage HA request within defined timeframe by HA : Renewal, Re-evaluation, Safety instruction, Patent, Orphan Renewal, Barcode registration
  • Timely inform the relevant stakeholders of the approval
  • Ensure the Regulatory Affairs database is updated with regulatory activities, timelines and priorities as per the Regulatory Standards and ensure accuracy of the data (GPRS, Local Tracking logs)

Requirements

  • Bachelor degree, or above majored in pharmacy. (Pharmacist is preferred.)
  • Total 3~8 years of experience and minimum 2 years of experience in RA of pharmaceutical company.
  • Knowledge of Pharmaceutical Affairs law and MFDS regulation.
  • Demonstrated excellence in documentation.
  • Good at communication, English and computer skill
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