At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Warsaw Masovian PolandJob Description:
Fueled by innovation at the intersection of biology and technology were 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 thats 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 patients lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at 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-OrientedRequired Experience:
Senior IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more