Global Regulatory Labeling Specialist

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.