Jobs

    Regulatory Assistant - Singapur, Singapore - E-PLOYMENT CONSULTANCY

    E-PLOYMENT CONSULTANCY
    E-PLOYMENT CONSULTANCY Singapur, Singapore

    1 week ago

    Default job background
    Description
    Roles & Responsibilities
    • Coordinate with laboratory, production and other relevant departments to gather registration requirements.
    • Coordinate with customers on registration requirements.
    • Arrange endorsement for regulatory documents.
    • Prepare registration documents according to country specific guidelines for submission to legislation authorities.
    • Consolidate and compile raw data, reference information and product technical specifications.
    • Assist in the preparation of GMP related requirements.
    • Prepare Safety Data Sheet (SDS) and GHS labels in accordance to Globally Harmonized System (GHS) standards.
    • Manage registration sample requests, receipts and dispatch by proper recording and monitoring and storage.
    • Liaise with relevant authorities (NEA, SCDF, SPF, HSA and MOM) on licensing, compliance and other legislative matters.
    • Evaluate new products if license is required according to local regulations.

    Job Requirements:

    • Diploma holder in life science, pharmacy, chemistry or related courses.
    • 1 year experience in GMP (Good Manufacturing Practice) and CTD (Common Technical Document) preparation.
    • Knowledge of GMP or major international regulatory such as ICH.
    • 5 day work week (Office hours).

    Interested applicants, please email your resume to -

    E-Ployment Consultancy

    EA License No: 09C0884

    EAP Name/ Registered No: Ivan Mah/ R1108310

    Tell employers what skills you have

    Licensing
    Cell
    Derivatives
    Due Diligence
    Labels
    Outsourcing
    Legislation
    Vetting
    GMP
    Assurance
    Chemistry
    Internal Controls
    Appeals
    Laboratory
    Manufacturing
    Conflict


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