Regional Regulatory Affairs SpecialistID:36639

4,000 SGD ~ 4,500 SGDCentral2 days ago

Overview

  • Salary

    4,000 SGD ~ 4,500 SGD

  • Industry

    Manufacturing(Pharmaceutical/Medical Equipment)

  • Job Description

    Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.

    You will be reporting to the eam Leader (Singapore).

    【 Responsibilities 】
    - Regulatory coordination with local Responsible Persons
    - Documentation & dossier management (ASEAN CTD, eCTD)
    - Compliance oversight & regulatory intelligence
    - Stakeholder engagement across multiple internal teams
    - Lifecycle management and post-approval changes
    - Electronic submission systems / regulatory tracking tool usage

Qualifications

  • Requirement

    【Requirements & Preferences】
    (Must)
    - Bachelor’s or Master’s in Pharmacy, Life Sciences, or related field
    - Minimum 3 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.
    - Familiarity with ASEAN CTD, ICH, country-specific regulations
    - Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.
    - Proactive, self-motivated, and able to take initiative with high energy levels.

    (Advantageous)
    - Possess regional exposure in APAC
    - Strong communication and negotiation skills.
    - Logical thinking and sound problem-solving capabilities.
    - Ability to adapt well to changes and work effectively under pressure.
    - Possess regional experience in a large pharmaceutical company is an advantage.

  • English Level

    -

  • Other Language

    -

Additional Information

  • Benefit

    【 What you will receive 】
    - AWS
    - Variable Bonus (Depends on Company and Individual performance)
    - Annual Leave 14 days
    - Medical Leave
    - Medical Benefits
    - Flexible Benefits (S$1500/year)
    - WFH: Once a week to be at Office, others day WFH

  • Working Hour

    9:00 ~ 18:00

  • Holiday

    -

  • Job Function

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