Job Description
To prepare New, Renewal dossier and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for China, South Africa, Mexico and Brazil filing and Regulatory knowledge of Guidelines viz, ICH, FDA PICs etc.
To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings.
To review and ensure accuracy of deficiency response for Quality, Clinical part of dossier.
To evaluate the query received for registered or under registration products and Tender products and to support for completion of the same in timely manner.
To maintain Data Bank for Commercial activity.
To work with quality standards and adherence to system.
To follow document control, deviation control and change control.
Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
