Regulatory Graphic Artist works closely and collaboratively with the Regulatory team, suppliers, and local clients in terms of facilitating artworks for PO and submission to FDA.
Specific Roles And Resposibilities
FACILITATES ARTWORKS FOR PO
- Receives SOF from Regulatory Head.
- Checks status if its with no change, with change and if its new order.
- Checks if theres amendment on going, will not accept the SOF if certification has not yet been received.
- Updates list of approved artworks/folder of approved artworks for our records.
- If it is new order, finalizes the artwork as per CPR and CPR attachment, per FDA correction/ guidelines and send it to supplier so they can finalize the artwork as per their machine settings.
- After finalization, prints the artwork and give it to concerned pharmacist for them to check the artwork before sending back to supplier with attached CPR.
- If the pharmacist has a correction on the artwork, will revise it and send to supplier.
- If it is Repeat order, will check the regulatory status because sometimes the CPR was amended. (e.g. Change in Packaging Design, CPR Transfer, Change in Distributor, renewed CPR, Inclusion of Trader).
- If it is Repeat order will check again the artwork if there are still minor corrections present.
- Double checks the artwork sent by supplier as sometimes they change some details on the artwork.
- Responsible in generating barcodes for clients and suppliers who are not providing barcodes.
- After checking of artwork received from supplier, will send the artwork to client for their approval.
- Advise supplier for provision of LSD for required products only.
- Follow up pending artworks to concerned supplier.
- Routing for approval
- Gets P.O # to Purchasing
- Scans all approved artworks and sends to manufacturer with P.O # for their reference.
- Answers some queries and e-mails of the supplier regarding artwork issues for their product/s.
- Updates the List of Approved Artworks (Regulatory and Purchasing Status).
- Forwards SOF2 to Purchasing
SNAP SHOTS/ARTWORK FROM SUPPLIER
- Checks snap shots or final artwork from supplier as per last approved artwork before they proceed for final printing.
CLIDPs INITIAL ARTWORKS
- Templates the packaging design per client and approved PCPR artwork
AMENDMENT ARTWORKS/ INCLUSION OF TRADER
- Arranges and revise artworks for amendment purpose as per Pharmacist/XD request.
- Change in Packaging design.
- Inclusions of AO 2016-008 complete details to artworks.
- If we dont have the final approved CDR file we will request it to concern supplier for them to send the editable CDR file for our reference.
RENEWAL ARTWORK
- Arranges artwork for renewal as per request of pharmacists.
- Reflects ADR details and other details compliant to AO 2016-008.
INITIALS
- Arranges artwork as per pharmacist request for INITIAL as per AMBICA corporate design.
- Checks insert as per SPC of Innovator product.
- Prepares mock-up for submission to FDA.
PRE-SHIPMENT SAMPLES
- Discuss products with issues to client/XD for approval.
- Double checks dimension, details and graphic design as per approved artwork because sometimes the supplier change it.
CHECKS LSD (as per approved artworks)
Other duties as may be assigned by the management.
Minimum Qualification
- At least 2-4-year course college graduate.
- Knows how to operate Corel, Illustrator, Photoshop, PDF and Microsoft Office Programs.
- Good English communication skills.
- Keen to details
- Highly self-motivated, goal oriented and committed in pursuing long term career.
- Exceptionally well organized and strong work ethics.
