Job Overview:
Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.
Summary of Responsibilities:
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally:
Prepare, compile and review product quality (CMC) and other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance, as applicable.
Create/revise/approve raw material and packaging specifications, and other associated documents, as applicable.
Coordinate and interact with cross functional teams/departments for evaluation/ impact assessment of change control, review implementation strategy and required documentation governing the change and manage OOS, OOT or other product related changes, if needed.




Support Financial data management, Business plan file creation and maintenance, Supplier data management and PO creation as required.
Support for creation and update of global labeling documents, its content and format, QC and other associated activities for the labeling projects, as applicable.
Support stability data evaluation and report preparation, dissolution profile evaluation etc. as applicable.
Perform literature search and preparation of various regulatory documents in support of excipients, APIs and/or drug products, as applicable.
Coordinate with stakeholders to understand and support import license requirements, investigation report drafting, record management and document coordination with internal and external department, as applicable.
Responsible for specifications setting/ justification, ensuring the Quality level for Laboratory support, perform Computerized System Validation (CSV) and upgradation of exis

📌 Regulatory Operations Specialist II (Mumbai)
🏢 Fortrea
📍 Mumbai