Piramal Enterprises - Healthcare Domain is one of the largest custom manufacturing companies in the world that provides flexibility and scalability of operations. We have created a vast network of contract development and manufacturing facilities located in North America, Europe and Asia that offers a multitude of services that cover the entire drug-cycle, from development and commercial manufacturing to off-patent supplies of Active Pharmaceutical Ingredients (APIs) and formulations. Our network enables us to deliver benefits by strategically placing projects to take advantage of low costs, local supply chains and specific customer/ market requirements.
Job Title: Executive - Regulatory Affairs
Qualification: B.sc/M.ScMicrobiology
Experience: 2-3 years
Job Description:
- Preparation and compilation of regulatory documents (DMFs / ASMFs) for filing with regulatory agencies and customers.
- Communication with concerned internal customers to address the technical queries on the dossiers and other regulatory submissions, including marketing related queries.
- Filling the customer questionnaires, adherence to QA systems and IT policies related to the electronic submissions (DMFs, ASMFs & SPLs) through ESG.
- Internal audits for regulatory compliance. Updating and organising with Pharmacopeia revisions, track record (electronic & paper) for all registered products.
- cGMP training-planning, and adequacy of the training. Monthly reports for RA activities.
How to apply:
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