Job Description

Purpose

This position will lead and be accountable for the pre-approval regulatory efforts in the US market.

Position / JobTitle

Senior General Manager/General Manager

Department

Regulatory Affairs

Reporting To

Director – Regulatory Affairs & IP

Location

Thane

Years of Exp

20+ years

Dosage Form

Know-how of all dosageforms

Job Responsibilities / Deliverables

  • Prepare Regulatory Strategies for US market.
  • Review and submit quality dossiers in the US market in line with regulatory strategy and expectations including Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs) or 505(b)(2) applications.
  • Plan and manage all pre-approval submissions including pre-IND, IND, pre-NDA, pre-ANDA, CGT requests and query responses.
  • Manage various filings including submission of meeting requests, teleconference requ...

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