Jobs

    Regulatory Affairs Manager - Singapore - RECRUIT EXPRESS PTE LTD

    RECRUIT EXPRESS PTE LTD
    RECRUIT EXPRESS PTE LTD Singapore

    1 week ago

    Recruit Express Pte Ltd background
    Description
    Roles & Responsibilities

    Job Scope

    • Supports JAPAC RA affiliates and Global RA in Marketing Authorization (MA) and clinical development related activities for the assigned projects.
    • Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction with regulatory agencies.
    • Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
    • Partners with intercontinental commercial, market access and medical to ensure business needs are met.
    • Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
    • Assesses scientific data for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
    • Manages clinical development, clinical trial, new drug applications and lifecycle activities for the assigned projects to ensure regulatory requirements are met and optimal regulatory strategies are reached.

    Requirement

    • Min Bachelor in pharmacy
    • Minimum 5 years' of regulatory experience in pharma industry

    Basic salary: $7K to $8K

    Interested applicants, please email your updated CV to

    Consultant: Huang Jingsheng Kevyn (R

    Recruit Express Pte Ltd (99C4599)

    Tell employers what skills you have

    FDA
    Regulatory Compliance
    Interpersonal Skills
    Regulatory Affairs
    ISO
    Market Access
    Clinical Development
    Biology
    Authorization
    Medical Devices
    Pharmacology
    Regulatory Requirements
    Life Sciences
    Manufacturing
    Personal Development


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