You are hereLabeling Associate / Specialist - Drug Regulatory Affairs Require @ Novartis
Labeling Associate / Specialist - Drug Regulatory Affairs Require @ Novartis
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Labeling Associate/Specialist - Drug Regulatory Affairs
Job Purpose (State in one sentence the overall objective of the job)
The Labeling Specialist ensures preparation and availability of artwork for printed packaging components for submission to FDA, for use in packaging of products for US commercial use and for world wide use for specific products.
Major Activities (Describe 8-12 main activities)
1. Work with the Graphic Arts Specialist to create artwork for printed packaging components.
2. Proofread text for labeling of pharmaceutical products as required by FDA (21 CFR 201).
3. Ensure that labeling artwork and proofs meet all medical, legal and regulatory requirements.
4. Ensure the accuracy of commercial packaging components.
5. Communicate with labeling managers in US to ensure any new US regulations are incorporated.
6. Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised text on labeling components.
7. Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for FDA submission and production (including sup-port of product launch).
8. Provide input for internal tracking database in order to control workflow and to ensure FDA submission and/or production deadlines are met.
9. Be responsible for assigning a unique text number to the package inserts ensuring the use of a correct version.
10. Provide editorial support to DRA managers by reviewing package inserts (new and revised) to ensure SPL/PLR compliance.
Key Performance Indicators (Indicate how performance for this job will be measured)
Artwork must be 100% accurate.
Artwork for packaging components must be completed and be available to meet submission and production schedules.
Ideal Background (State the preferred education and experience level)
Knowledge of pharmaceutical labeling, packaging components, regulations, XML, SPL initiative, labeling process
Experience/Professional requirement: Experience with labeling submissions
Experience: 4-8 years
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
Job Type: Full Time
Employment Type: Permanent
Job ID: 83133BR
End Date: 8th August, 2011
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