概述

• 薪资

  5,000 SGD ~ 5,700 SGD

• 工作行业

  Manufacturing(Pharmaceutical/Medical Equipment)

• 工作内容

  Our client, a Japanese pharmaceutical company, is seeking a highly motivated and detail-oriented Regional Regulatory Specialist based in Singapore. This role supports regulatory activities across Asia and the Middle East (excluding China and Japan). You will contribute to the preparation and coordination of regulatory submissions, post-approval change applications, and regulatory intelligence efforts, collaborating with internal teams and local corporate representatives to ensure accurate and timely regulatory operations.
  
  You will report to the Team Leader (Singapore).
  
  【 Responsibilities 】
  1) Regulatory Document Preparation & Coordination
  - Coordinate the preparation and review of regulatory documents for the territory. Support the compilation and maintenance of country-specific regulatory requirements (as applicable).
  - Post-Approval Change Application Support: coordinate the preparation of post-approval change applications, including:
  ・ Artwork & Package Insert changes
  ・ CMC changes
  ・ Other lifecycle management submissions
  - Track change request status, timelines, and queries from local company representatives.
  
  2) Regulatory Research, Analysis & Sharing
  - Conduct research on regulatory requirements, guidelines, and updates relevant to OIAA markets.
  - Summarize and share regulatory intelligence internally through reports, trackers, or briefing slides.
  - Support proactive identification of regulatory risks and opportunities.
  
  3) Stakeholder Coordination
  - Coordinate with internal functional teams (CMC, Labelling, Support & Promotion, QA, PV, Business Teams) to gather required information for submissions.
  - Support communication and follow-up with local partners and Responsible Persons to ensure timely submissions and responses.
  - Build professional working relationships across internal and external stakeholders.
  
  4) Documentation & Systems
  - Support local companies and their designated Responsible Persons to maintain accurate regulatory records and trackers in electronic systems.
  - Support document archiving and version control management.
  - Assist in ensuring compliance with internal SOPs and regulatory documentation standards.