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Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today.



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Inviting applications for the role of Regulatory Affairs Analyst

The Role demands for a publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to.

Responsibilities

Publishing and performing technical validation of eCTD for US submissions.
Performing final technical quality review.
Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority.
Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders.
Capturing submissions-related correspondence from health authorities, such as uploading documentat

📌 Regulatory Affairs professional with experience in global eCTD/CTD/NeeS/ACTD submissions (Ciudad de México)
🏢 Genpact
📍 Ciudad de México