Johnson & Johnson Careers

EMEA Regulatory Affairs Professional, Artwork Management

Warsaw, Poland
Regulatory Affairs


Job Description

Requisition ID: 1905741576W

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.

 

EMEA Regulatory Affairs Professional, Artwork Management

Location: Warsaw Poland

Contract: Permanent

Main tasks:
  • Use of ePackMat 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, Graphic Services, logistics/supply chain & production plants internal/external to interpret current stock/orders to best anticipate ex-works date (available for delivery (AFD)) to meet both Health Authorities 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


Qualifications

Crucial requirements for candidates:

  • Experience of working in a virtual team and/or global organization would be an asset.
  • Previous experience in Regulatory Affairs Junior 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
  • Proficient level of English language
  • Great attention to details and sense of responsibility 
In return, we offer:
  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Many opportunities to work on challenging projects and assignments.
  • Possibilities for further personal as well as professional development.
  • Many employees benefits.


Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Janssen-Cilag Polska Sp. z o.o. (7824)
Job Function
Regulatory Affairs
Requisition ID
1905741576W