
Assistant General Manager
7 days ago
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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