Senior Manager – ANDA

8 - 12 Years

Job Description

  • Regulatory support and review for pre-filing and development documentation.
  • Coordination with internal and external stakeholders for regulatory filing related documentation.
  • Review, compilation and authoring of CMC, biopharmaceutics, labeling, module 1 document 
  • Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc. 
  • Authoring, Compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier 
  • Authoring, Compilation and review of Structure Product Labeling (SPL) 
  • Consulting, categorizing, authoring Post approval changes through appropriate supplements. Submission of annual reports on respective anniversary dates
  • Participation in regulatory audits from US FDA and provide regulatory support

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Employment Type:Permanent Job, Full Time


Desired Candidate Profile

Please refer to the Job description above


UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile

Unichem Laboratories Ltd

We are a leading pharmaceutical company with an increasing focus on innovative research and developed markets. To augment our efforts in achieving our expansion and business plan we invite young and energetic people to take up responsible positions in our organisation
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Recruiter Name:Samir Gaikwad

Contact Company:Unichem Laboratories Ltd