Executive – Regulatory Affairs

2 - 4 Years
Mumbai, Mumbai Suburbs

Job Description

Job Description:
  • Preparation of ANDAs and assistance for document review of all projects.
  • Life cycle management of ANDAs (through Annual Reporting, Post approval supplements).
  • Deficiency responses and labeling amendments.
  • Timely submission of ANDAs, Annual reports & post approval variations.
  • Ensuring accuracy and adequacy of the registration documents required for upcoming new ANDAs.
  • Compilation of ANDA submission.
  • Compilation and submission of CBE-0, CBE-30, PAS, Leading supplements, annual reports.
  • Generation and submission of SPL for drug listing.
  • Provides responses to queries received from US FDA.
  • Review and comment on technical documents related to dossier compilation or query response.
  • Maintaining department records as assigned.
  • Co-ordination and communication with cross functional team members to ensure the submission within stipulated timeframe.
  • Any other responsibility assigned by Head of the Department.

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