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  • Regulatory Affairs Executive - Singapore - ABIORES PTE. LTD.

    ABIORES PTE. LTD.
    ABIORES PTE. LTD. Singapore

    2 weeks ago

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    Description
    Job Description:

    We are seeking a highly skilled and experienced professional to fill the role of Regulatory Affairs Specialist.

    1. Prepare and submit product registration dossiers, design performance evaluation studies, and manage their execution with Clinical Research Organizations (CROs).
    2. Serve as an expert on medical devices laws and regulations for product registration in our target regions.
    3. Interface with regulatory agencies, track progress, and resolve issues raised during the review process.
    4. Contribute to product testing, clinical verification, data collection, and tracking efforts.
    5. Submit scientific special projects to regulatory agencies on behalf of the company.
    6. Establish strong relationships with key opinion leaders and regulatory bodies.
    7. Collaborate with cross-functional teams to achieve project goals and align with organizational objectives.

    Key Qualifications:

    1. Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
    2. Strong project management skills, including planning, execution, and timely communication. Excellent presentation skills.
    3. Proactive work attitude, strong communication and execution abilities, results-driven, and a team player.
    4. Meticulous and responsible individual who can handle stress and tight schedules effectively.

    About You:

    • Clinical Research experience.
    • Knowledge of Clinical Research Organizations (CROs).
    • Able to work well under pressure.
    • Regulatory Affairs expertise.
    • Critical thinking skills.
    • Oncology and Biotechnology knowledge.
    • Medical Devices understanding.
    • Change Control and Presentation Skills.
    • Familiarity with Regulatory Requirements.
    • Life Sciences background.

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