Regulatory Affairs Professional ERMC Artwork Management

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:

Pefki, Attiki, Greece

Job Description:

RA Professional ERMC Artwork Management

The Regulatory Management Center is a new regional organization to handle most of Local Operating Companies activities led by senior regional regulatory staff, where they will handle tactical Life Cycle Management processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded EMEA region, and it will work in close collaboration with the respective Local Operating Companies and regional and global departments.

Responsibilities:

• Use of Artwork management System to initiate artwork for new labelling or changes to current labelling into production and/or generation of mock-up needed for regulatory submissions
• Complete review of the artwork (using electronic tool, where possible) and co-ordinate the final approval of the artwork with Local Operating Companies driven by the agreed deadlines.
• Entering data and using tools to monitor metrics for tracking of implementation of packaging material
• Liaise with Local Operating Companies Regulatory Affairs, quality, Product Artwork, supply chain, packaging sites internal/external to meet both Health Authorities implementation timelines and minimize current stock /component write off costs
• Performing and/or co-ordination of Quality Check (QC) of local Product Information
• Communication with local stakeholders of the Local Operating Companies in scope during the review process

Requirements:

• Previous experience of 2 years in Regulatory Affairs and artwork management
• Experience of working in a virtual team and/or global organization would be an asset
• Experience in working with limited supervision and able to make independent decisions is of advantage
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment
• Experience with computer systems usage (MS office, excel)
• Proficient level of English
• Knowledge of multiple languages would be an asset
• Accuracy, precision and respect of timelines is mandatory