Regulatory Affairs 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.