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Assistant Manager
Umedica Laboratories Private Limited
Mumbai
Not Disclosed
5 - 10 Years
Full Time - Permanent
Views:300
Applicants:1
Posted on 8 Sep, 2025
In Office
Job Description | Responsibilities
- Prepare and submit Pre-IND requests/packages,IND/NDA submissions per FDA & EMA guidelines
- Define nonclinical & clinical study needs for 505(b)(2) incl. bridging studies
- Prepare CTD dossiers (Modules 1-5) & review CMC docs
- Handle comparability,bioequivalence & formulation issues
- Manage post-approval variations,renewals and compliance
Overview
- Industry - PHARMACEUTICAL / MEDICAL DEVICES / CRO, Biotech / Biopharmaceuticals
- Functional Area - Regulatory Affairs / Corporate Affairs
- Job Role - Regulatory Affairs Specialist, Associate Manager - Regulatory Affairs
- Employment type - Full Time - Permanent
- Work Mode - In Office
Qualifications
- Any Graduate - Any Specialization
- Any Post Graduate - Any Specialization
- Any Doctorate - Any Specialization
Job Related Keywords
Regulatory Affairs
FDA
EMA
CMC
Compliance
