EMEA Artwork Regulatory Affairs Specialist

Biopharma Careers; Warszawa; Hybrid; PLN 95,000 - 152,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Professional Artwork Management for the EMEA region based in Warsaw, Poland (or Cairo, Egypt). This one-year fixed-term contract focuses on preparing artwork for labeling and regulatory submissions.

You will coordinate reviews, manage labeling changes, and collaborate with LOCs and cross-functional teams to meet timelines. The role requires a Bachelor's degree with 2 years in Regulatory Affairs/artwork management; a Master's is a plus.

Qualifications

• Bachelor's degree with previous experience of 2 years in Regulatory Affairs and artwork management.
• Master's degree would be an asset.
• 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.
• Proficient level of English.
• Knowledge of multiple languages would be an asset.
• Accuracy, precision and respect of timelines is mandatory.

Responsibilities

• Prepare artwork input files or annotated artwork for mockups or artwork creation.
• Use artwork management system to initiate artwork for new labelling and changes to current labelling and/or creation of mockup needed for regulatory submissions.
• Perform and complete the quality check review of the artwork and co-ordinate the final approval of the artwork with LOCs.
• Enter data and use tools to monitor metrics for tracking of implementation of packaging material, manage Artwork action items in the labeling tracking system.
• Effectively communicate with applicable internal and external stakeholders throughout the process of artwork development, establishing timelines.
• Ensure implementation of standardization/new systems and processes to ensure efficiency gains and to support business continuity.

Skills

English proficiency

Education

Bachelor's degree

Master's degree

Tools

MS Office

Excel

Job description

Johnson & Johnson is seeking a Regulatory Affairs Professional Artwork Management for the EMEA region based in Warsaw, Poland (or Cairo, Egypt). This one-year fixed-term contract focuses on preparing artwork for labeling and regulatory submissions.

You will coordinate reviews, manage labeling changes, and collaborate with LOCs and cross-functional teams to meet timelines. The role requires a Bachelor's degree with 2 years in Regulatory Affairs/artwork management; a Master's is a plus.