Regulatory Affairs - Formulations

15 - 24 years

30 - 40 Lacs

Posted:4 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Roles and Responsibilities

  • Manage ANDAs (Abbreviated New Drug Applications) for US market approval.
  • Prepare DMFs (Dossier Management Facility) for regulatory submissions.
  • Ensure compliance with FDA regulations and guidelines throughout product lifecycle management.
  • Collaborate with cross-functional teams to develop formulations that meet regulatory requirements.
  • Provide expertise on drug regulatory affairs, including labeling, claims, and risk assessment.

Desired Candidate Profile

  • M.Pharma degree from a recognized institution.
  • Minimum 15-24 years of experience in Regulatory Affairs - Formulations.
  • Strong understanding of FDA regulations and guidelines.
  • Excellent communication skills for effective collaboration with stakeholders.

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