To review CMC documents for submission. Preparation of DMF/ASMF in eCTD format for submission to USFDA, EDQM,NMPA,CADIFA and ROW countries.Life cycle management of submitted DMFs and ASMFs. Preparation of Applicants Part of DMF and Technical Packages
Required Candidate profile
Change Control evaluation and documentation.
To conduct meetings with cross functional teams & share requirements to respond to the deficiencies within timeline.
FDA Annual Regulatory Registrations.
📌 Executive / Sr Executive / Asst Manager And Manager Indore (India)
🏢 Balaji Enterprises
📍 India
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