Company: Teva Pharmaceuticals Ltd
Post: Regulatory Affairs
Experience: 1-2 yrs
Qualification: Msc/MPharm/BPharm
Location: Mumbai
Job description
- RA Labeling responsibilities: Develop labeling documents to ensure alignment with the Reference Listing Drug. This includes QC, proofing, editing and formatting of documents, and coordinating the review and approval of final submission documents with US Labeling Team members.
- Create, revise, and prepare labeling documents needed for full responses to FDA via appropriate filing mode. This includes but is not limited to the development of the content of labeling, side-by-side comparisons and other required submission materials, as necessary.
- Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool TVT.
- Work with US Regulatory Labeling Team to ensure assigned projects like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives, etc. and any other projects, as per requirement, are submitted on-time following the eCTD requirements related to labeling.
- Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling
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