5.0 - 10.0 years

0 Lacs

karnataka

On-site

As a Regulatory Affairs Labeling Specialist, you will be responsible for creating a labeling strategy for health authority interactions and handling labeling queries from Health Authorities (HA) or Country Organizations (CO) for the assigned program/products. Your key duties will include ensuring artwork management for initial submissions/commercial launch activities in coordination with the Cross-Functional Team (CFT). Additionally, you will participate in the review of promotional materials and represent Regulatory in CFT meetings to make strategic decisions ensuring no misleading information is provided. You will also be responsible for coordinating with external vendors to prepare/review translated documents to support Global Regulatory Submissions. Your role will involve preparing Structured Product Labeling (SPL) for initial submissions/labelling responses and drug listings for approved products according to business/agency timelines. You will also oversee the change management process of Company Core Data Sheets (CCDS), Non-CCDS, and annual reportable labeling changes. Furthermore, you will analyze competitor information such as labels and approval packages for regulatory policy projects and/or labeling projects. It will be your duty to escalate, notify, and resolve any issues that may impact the final labeling submission. You will be accountable for maintaining an internal tracker for CCDS, Non-CCDS, and annual reportable labeling changes and submissions. Additionally, you will manage Global Labelling Impact Assessment, including Reference Listed Drug (RLD) updates and Safety Information Updates. A key part of your role will involve leading and directing the Labelling Team members to adhere to business processes and ensure high-quality work from the first instance. To be successful in this role, you should possess a degree in B. Pharmacy/M. Pharmacy/B.Sc./M.Sc. along with a minimum of 5 to 10 years of experience in the Global Labelling domain.,

Posted 6 days ago

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