Job Title

Key Responsibilities:  Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.  Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team.  Responsible for Promotional Material Review and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information.  Responsible to Coordinate with External Vendor to ensure Translations documents are prepared / reviewed to support Global Regulatory Submissions.  Responsible for SPL Preparation for Initial Submission / Labelling Response and Drug Listing for Approved Products as per business/agency timeline.  Change management process of CCDS, Non-CCDS and Annual reportable labelling changes.  Analysis of competitor information (e.g., labels, approval packages) for regulatory policy projects and/or labelling projects  Escalate, notify, and resolve any issues that may impact final labelling submission.  Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions.  Responsible for managing Global Labelling Impact Assessment (RLD update / Safety Information Update).  Manage Labelling Team members and direct them to follow as per business process and ensure first time right quality.Minimum Qualifications and Experience B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Relevant - Minimum 10 to 15 years and above of experience in Global Labelling domain Preferred Skills Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.  EAective time management and organizational skills to eAiciently manage multiple time-sensitive assignments simultaneously.  Proactive identification of potential label issues/gaps and develop global regulatory label negotiation strategy with contingency planning.  Research and understand the labeling topic including reviewing labels across diAerent markets, competitor labels, study information, labelling regulations, etc.  Involved in People Management Activity –Hiring, Training and mentoring associates, leave management, appraisals, KRAs.  Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.  Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.  EAectively communicates diAicult issues both verbally and in writing to build alignment around a complex situation and process.  Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.  Depending on experience level, mentor newly hired staA or lead a team of junior staA.  Flexibility in responding to changing priorities or dealing with unexpected events.  Capability to handle multiple priorities and balance work to achieve business goals.