Executive - DRA EM

Alkem Labs; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Alkem Labs in Mumbai is seeking a Regulatory Affairs professional to prepare New and Renewal dossiers and variations for CIS countries with knowledge of Kazakhstan, Russia, Tajikistan and Uzbekistan guidelines (ICH, FDA PICs). The role involves ensuring data accuracy before submissions and maintaining regulatory compliance across multiple markets.

Responsibilities include coordinating with authorities, gathering information for tenders, addressing product queries, and supporting site audits and

Responsibilities

• To prepare New, Renewal dossier and variations (Site/ Formula) of CIS countries and having specific knowledge for Kazakhstan, Russia, Tajikistan and Uzbekistan 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 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.

Job description

Responsibilities

• To prepare New, Renewal dossier and variations (Site/ Formula) of CIS countries and having specific knowledge for Kazakhstan, Russia, Tajikistan and Uzbekistan 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 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.