Assistant General Manager

7 days ago

Mumbai, Maharashtra, India Ipca Full time ₹ 15,00,000 - ₹ 20,00,000 per year

Greeting from Ipca Laboratories

Opening in Regulatory Affairs Formulation

Qualification : B pharma /M Pharma /Msc

Experience : 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage forms

Designation : Assistant General Manager

Location : Kandivali

Key Responsibilities:

  • Ensure timely submission of ANDAs, supplements and amendments
  • Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for adequacy and correctness
  • Life cycle management of product including maintenance, updation of changes to approved ANDAs
  • Technical support at drug product development stage
  • Keep abreast of latest regulations, interpreting and understanding guidance and disseminating the information to all concerned

Key activities :

  • Review of registration applications, amendments, supplements and annual reports for onward submission to USFDA.
  • Training of subordinates on regulatory requirements
  • Discuss and coordinate with technical dept. to ensure regulatory compliance throughout the life-cycle of product from formulation development and manufacturing of product to marketing authorization and post-approval changes
  • Regulatory support to manufacturing sites during audits
  • Life-cycle management of approved ANDAs
  • Review and Approval of Change Control Proposals
  • Monitoring and tracking of Regulatory database
  • Support to marketing for commercial and launch activities
  • Gap assessment of approved ANDAs wrt compliance to current requirements prior to product launch
  • Evaluation and assessment of impact of post approval changes, regulatory strategy determination for supplement filing category

Interested candidate can share the profile at sunita.fernandes

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