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Regulatory Affairs Specialist (Germany)

ProductLife Group

Germany, Germany, Germany Full-time July 26, 2026
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Vacancy Description

PLG is seeking a motivated and detail‑oriented Regulatory Affairs Specialist to join our Regulatory Affairs team.

In this role, you will be responsible for Regulatory Affairs activities primarily for Germany, with exposure to other EU markets, ensuring compliance throughout the full product lifecycle, from registration to post‑approval maintenance.

Responsibilities:

1. Submission & Registration Activities

  • Prepare, compile, and submit Marketing Authorisation Applications (MAA), including new MAAs and variations, for Germany and assigned EU countries.

  • Support Orphan Drugs, line extensions, and launch readiness activities.

  • Contribute to registration strategies and timelines in collaboration with PLG project teams and clients.

    • 2. Product Lifecycle Management

  • Manage post‑approval activities, including: Variations
    Renewals
    Product Information (SmPC, PIL, Labe...

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    Vacancy Details

    Location Germany, Germany
    Country Germany
    Type Full-time
    Category Business Operations Specialists
    Posted July 26, 2026

    About ProductLife Group

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    ProductLife Group

    Germany, Germany

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