Documentation Specialist

2 days ago


Mumbai, Maharashtra, India Novartis Full time

Sandoz, a global leader in generics and biosimilars, is shaping the future of medicine. We are seeking an experienced Documentation Specialist to join our team.

The successful candidate will ensure a controlled documentation system, record retention, and information services, including electronic records retention processes in accordance with regulatory requirements. They will also ensure compliance with regulatory agency requirements, maintain technical and non-technical documentation change systems, and assure procedures for classifying and maintaining records.

The ideal candidate will have experience in new submissions and life cycle management in major markets (EU, US, CAN, JP, AUS, BR, CN), as well as in managing administrative changes, QP declarations, GMP certificates, CEPs, import permissions, COPPs, legalizations, Apostille, translations, sample management, and other regulatory requirements.

In this role, you will identify required documentation for regulatory submissions, negotiate the delivery of approved technical source documents, and manage project timelines. You will also keep knowledge up-to-date with regard to regulatory guidelines and requirements in all regions, as well as new technical trends.



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