138 684
20 326
Regulatory Affairs Group
Regulatory Product Submissions and Registration
Professional
Warsaw, Masovian, Poland
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An internal pre‑identified candidate for consideration has been identified. However, all applications will be considered.
Conduct initial screening of copy approval material in particular: verify metadata of the assets and adherence to procedures, then route to approvers for first‑time review, subsequent review, or re‑approval in compliance with procedures (40%)
Review and release final materials in a timely manner (30%)
Co‑ordinate (Implement and Track) progress of submissions in copy approval system and follow‑up with submitters and reviewers to ensure timelines are met for their respective tasks (15%)
Review submissions and attachments for accuracy, acceptability, and completeness to determine if the document is ready for review
Assign appropriate reviewers based on their responsibilities defined in the EMEA copy clearance SOP and by local guidelines/teams
Assign appropriate timelines for reviewers based on the procedure
Establish material review priorities, in partnership with project owners to ensure prioritization of business initiatives
Release final materials
Direct inquiries to appropriate personnel regarding copy approval process and system for EMEA region (5%)
Provide bespoke reporting ad hoc, requesting the support of global where required, to support copy clearance procedure and regional requirements
Drive in collaboration with the Copy Clearance Manager an effective, efficient and compliant submission process (e.g. prioritization of business‑critical submissions, pre‑alignment facilitation, pre‑submission verification) (10%)
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail‑Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety‑Oriented
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail‑Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety‑Oriented