6 months ago
218 Views

Remote in Croatia, Regulatory artwork admin, Global company, Croatia

Job Posts

Navigate and Sustain Regulatory Artwork ComplianceMy client is looking for an experienced RA candidate who has good foundation in Regulatory Affairs and is able to work without much supervision.


The company is a well-known household name so experience here will give you a strong boost to your CV and will provide a different angle in your professional career.

You will be able to work quite autonomously within a very experienced team so still be able to learn new skills.

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 the 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

Requirements:

* 2+ years in Regulatory Affairs and artwork management experience
* Experience in 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
* Experience with computer systems usage (MS office, Excel)
* Proficient level of English and Croatian
* Accuracy, precision and respect of timelines is mandatory

Benefits:

* Top industry employer
* Flexibility to work remotely in Croatia
* Excellent experience on your CV that will give a boost to your career

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