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  • Senior Global Regulatory Affairs Specialist - Johannesburg - ICON

    ICON
    ICON Johannesburg

    2 weeks ago

    Default job background
    Technology / Internet
    Description

    Senior Global Regulatory Affairs Specialist

    We are seeking a Senior Global Regulatory Affairs Specialist to join our team.

    Key Responsibilities:

    • Coordinate central submissions to ensure adherence to contractual timelines.
    • Communicate submission status updates and collaborate to mitigate risks to Sponsor deliverables.
    • Provide information on regulations governing clinical trials at a project level.
    • Address Sponsor queries related to regulatory and submission requirements.
    • Prepare Core Clinical Trial Applications and perform quality control on central submission packages.
    • Support Business Development efforts with regulatory input for Requests for Proposal, Requests for Information, and Bid Defence Meetings.

    Your Profile:

    • Bachelor's degree in a scientific discipline or related field.
    • Minimum 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
    • Strong understanding of global regulatory requirements and guidelines.
    • Excellent communication skills in English.
    • Ability to work independently and collaboratively in a fast-paced environment.

    What We Offer:

    • Competitive salary.
    • An inclusive and diverse culture that rewards high performance and nurtures talent.
    • A range of additional benefits including annual leave entitlements, health insurance offerings, retirement planning, and more.

    We strive to provide an inclusive and accessible environment for all candidates. If you need a reasonable accommodation for any part of the application process, please let us know.


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