Position Overview
PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist 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...