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 : Associate II, Labeling Regulatory Affairs
Job Description
The Associate II, Labeling Regulatory Affairs will prepare, review, approve and manage labeling for pharmaceutical products for FDA submission in accordance with FDA regulations. Main focus will be working with third party, authorized generic, and private label customers. Responsible for the creation, approval, and maintenance of third party, private label, and authorized generic labeling. Responsible for the creation of pharmaceutical labeling drafts for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Sandoz requirements. Responsible for the creation of labeling in SPL and PLR format. Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA. Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements. Responsible for maintenance of all labeling files in accordance with internal procedures.
Candidate Profile
- Bachelors Degree or equivalent experience
- A minimum of 3 years of Pharmaceutical Labeling experience required.
- Must have ability to take and follow directions.
- Familiarity with FDA Labeling guidelines (21 CFR) required.
- Must possess excellent communication and organizational skills, be a team player and have a meticulous eye for details.
- Must be comfortable with PC Programs such as Word, Excel, and PowerPoint.
Additional Information:
Experience: 3 years
Location: Princeton, NJ
Education: Bachelors Degree
Industry Type: Pharma
Functional Area: R&D
Job ID: 239387BR
End Date: 10th May, 2018
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