India

Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products

Gathers, analyzes and documents user requirements for various business initiatives. Liaisons with IT and ensures requirements are appropriately translated into design specifications for systems and reports. Thermo Fisher Scientific

To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.

Operate assigned production and packing machines as per approved SOPs and work instructions. Perform machine start-up, operation, adjustment, and shutdown activities as per established procedures. Piramal Pharma Solutions

Accountable for performance and results of Submission Management sub-team team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.

The Clinical Data Manager is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables.

Smart Diagnostics of Rotating Machinery: A Digital Twin Approach for Industries using Physics-Based Simulation and AI/ML. IIT Bombay

Contribute to the preparation (including authoring, where relevant) and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and/or regional perspective.

Having excellent knowledge of product/account to enable meaningful interactions with clients and authors, including consultancy where necessary.