Labeling Specialist

As a Regulatory Affairs Labeling Specialist, your role involves creating a labeling strategy for health authority interactions and handling labeling queries for assigned programs/products. You will ensure artwork management for initial submissions/commercial launch activities in coordination with the CFT team. Additionally, you will review promotional materials and participate in CFT meetings to represent Regulatory in strategic decisions. Your responsibilities also include coordinating with external vendors to prepare/review translation documents for global regulatory submissions and preparing SPL for initial submissions/labelling responses and drug listings as per business/agency timelines. You will manage the change management process for CCDS, Non-CCDS, and annual reportable labeling changes, as well as analyze competitor information for regulatory policy and labeling projects. In case of any issues that may impact final labeling submission, you are required to escalate, notify, and resolve them promptly. You will also be responsible for maintaining internal trackers for labeling changes and submissions, as well as managing the Global Labelling Impact Assessment. Moreover, part of your role involves managing the labeling team members, directing them to follow the business process, and ensuring first-time right quality. Qualifications and Experience: - B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. relevant degree - Minimum 5 to 10 years of experience in the Global Labelling domain,