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Executive / Sr. Executive / Asst. Manager and Manager

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Onsite

Executive / Sr. Executive / Asst. Manager and Manager

BALAJI ENTERPRISES

Executive / Sr. Executive / Asst. Manager and Manager

2 months ago

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Important information


Contract type:

Permanent

Location:

Indore, Madhya Pradesh, India

Work mode:

Onsite

Published on:

11 August 2026

What they need


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.

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