To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.
Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.
Responsible for designing overall marketing and communication strategy of brands. Sales & Market data analysis. Knowledge of product strategy, product launch.
Plan and execute experiments in agreement with quality risk management and GDevP, GMP -Assists in the preparation of and reviews of the technological part of dossier
Conduct QC testing on raw materials, packaging, stability, in-process, and finished products. Capable of Handling Instrument like HPLC, GC, IR,UV instrument. Knowledge of Dissolution tester, KF, Potentiometer.
Unichem Laboratories Ltd., is looking for dynamic individuals with ambitious career aspiration having Regulatory Exposure for the opportunities at our pharmaceutical facility in Ghaziabad
Prepares, literature review, abstracts, posters, and slide sets, and Manuscripts sophisticated working from various data sources including clinical study reports, patient profiles, protocols etc.
Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.