Archerchem Healthcare logo

Regulatory Affairs Manager - API

6 - 11 years

5 - 10 Lacs

mumbai mumbai suburban mumbai (all areas)

Posted:2 days ago| Platform: Naukri logo

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Skills Required

regulatory affairs api active pharmaceutical ingredient drug master files dmf drug regulatory affairs ctd usfdf api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Affairs - API DMF

Experience:

Job Responsibilities:

  • Review and evaluate API Drug Master Files (DMFs) for regulatory compliance.
  • Assess manufacturing processes, controls, specifications, and analytical data.
  • Review CTD Module 3 sections related to API.
  • Identify deficiencies and prepare review comments and queries.
  • Ensure compliance with global regulatory guidelines (US FDA, EU, WHO, ICH).
  • Support regulatory submissions, responses to queries, and lifecycle management.
  • Coordinate with internal teams (QA, QC, Manufacturing, RA).
  • Stay updated with current regulatory requirements and guidelines.

Key Skills & Requirements:

  • 6+ years of experience in API DMF review or regulatory affairs.
  • Strong knowledge of API manufacturing and quality systems.
  • Hands-on experience with US FDA DMFs and global submissions.
  • Familiarity with ICH guidelines and GMP requirements.
  • Excellent analytical, documentation, and communication skills

Location - Malad

Salary range - 5 lacs to 10 lacs

interested candidate please mail me your cv on hr@archerchem.com or what's up your on 9028871352.

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