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Regulatory Affairs Specialist (Poland)

๐Ÿข
ProductLife Group
๐Ÿ“ Poland, Poland
๐Ÿ“
Location Poland
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Posted June 24, 2026
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Commute Local Area
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Job Description

PLG is seeking a motivated and detail-orientedย Regulatory Affairs Specialistย to join our growing life sciences company. In this role, you will ensure global compliance with regulatory requirements throughout the product lifecycle, from development and approval to post-market maintenance.

Responsibilities:

1. Submission and Approval Process:

  • Prepare and submit Manufacturing License Applications (MLA) for new products and site transfers.

  • Lead the preparation and submission of Marketing Authorization Applications (MAA) across Polish and global markets.

  • Support Technical/Site Transfer Applications for product launches and changes.
  • 2. Lifecycle Maintenance:

  • Manage post-approval regulatory processes, including Variations, Renewals, and Marketing Authorization Holder (MAH) Transfers/Certificates of Analysis (COA).

  • Handle updates to product Labeling, Line extensions, Product Information, Ar...
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    ๐Ÿ“ Location Details

    ๐ŸŒ†
    City
    Poland
    ๐Ÿ—บ๏ธ
    Country
    Poland
    ๐Ÿš—
    Commute
    Local Area

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