DRA (Drag Regulatory Affair) Assistant Manager

1 day ago

Gurgaon, Haryana, India Bal Pharma Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Roles and Responsibilities (5 days working)

  • Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets.
  • Handle team responsibilities related to dossier compilation, review, and approval.
  • Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization.
  • Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines.
  • Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation.

Desired Candidate Profile

  • M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs.
  • Strong understanding of CTD ACTD format for regulatory submissions (USFDA & EU).
  • Experience working on Solid Orals formulations is essential.
  • Excellent communication skills for effective collaboration with internal stakeholders and external partners.

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