Jobs

    Senior Regulatory Affairs Specialist - 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

    Salary: up to $6.5k

    Job Duration: June 1st 2024 – May 31st 2025

    Working Days & Hours: Mon - Fri Office Hours

    Location: Buona Vista

    Job Description:

    • 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.

    Job Requirements: Min Degree in Pharmacy/Biology with 5 years relevant experience

    Interested candidates, please submit your resume to:

    Ally Audrey Lok Xin Woon

    Recruit Express Pte Ltd (Healthcare & Lifescience)

    Company EA Licence number : 99C4599

    Personnel EA License: R

    Tell employers what skills you have

    FDA
    Regulatory Compliance
    Interpersonal Skills
    Regulatory Affairs
    Healthcare
    ISO
    Regulatory Strategy
    Market Access
    Clinical Development
    Biomedical Engineering
    Surveillance
    Compliance
    Authorization
    Medical Devices
    Audits
    Regulatory Requirements


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