Job Overview:
• Perform various project management and regulatory affairs activities for Fortrea clients.Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required. Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable.The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.Provide all clients, both internal and external, with the appropriate quality of service in a protected and cost-effective manner.

Summary of Responsibilities:
• Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client sites.




• Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations.
• Responsible for to coordinate with CRO and ensure that project complete with in timeline.
• Designs scientific experiments. Actively and personally monitor lab work. Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information.
• Responsible for the preparation of test methods, technical documents, protocols and reports whenever required
• Is responsible for the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, reviews data and draws conclusions.
• Analyzing and drawing interpretation out of the dissolution data sets.
• Trouble shooting the problems associated with instruments or methods.
• Performing activities following the GMP/ safety requirements related t

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