At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job Posting Locations:** Warsaw, Masovian, Poland **Job Description:** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **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%) **Required Skills:** **Preferred Skills:** 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