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Associate Regulatory Operations
1 week ago
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Our 109,000 colleagues serve people in more than 160 countries.Job description for the role.
- Good hands on understanding of MS word and PDF feature functionalities, styles, formats
- Good with making the document submission ready by formatting the documents using inbuilt tools and technologies
- Hands on exposure to ISI Toolbox plug in
- Associate will be responsible for performing quality checks of documents (format perspective)
- Will be maintaining and managing documents in Document management system. Responsible for managing the workflow and version controlling of the documents in the system
- Manages the country specific dossier structure across varied regions (especially non eCTD countries)
- Supports submission compilation of documents into country specific structures
- Fixes Best practices to make the documents submission ready
- Interacts and coordinates with key stakeholders like Regional Product leads, affiliates, CMC and other Global Regulatory Strategic teams
- Maintains request level data through effective trackers which is used for Monthly reporting of the data
- Need to have excellent communication skills (Oral and written)
- Exhibit team spirit and manage timely delivery of importing of documents into Document Management system or any other adhoc requests in time
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Mumbai, Maharashtra, India Abbott Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. ...
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