Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions & Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits.
Post : Manager - Corporate Regulatory Affairs
Job Description
- Review and approval of submission related documents from sites along with TTDs.
- Review and compilation of dossiers to target markets (ex: US ANDA) for solid Orals and Injectables.
- Annual renewal of DUNS number for all Indian sites of Piramal Healthcare. Establishment registration & Self-
- Identification of allocated sites to meet regulatory compliance with FDA.
- Checking feasibility of RFP proposals & providing Regulatory costing to BD/PM.
- Preparation of departmental SOPs, maintenance & training.
- Creating Regulatory awareness on guidance by way of presentations to cross functional teams.
- Review and approval of post approval changes for approved products.
- Responding to Customer Queries
- Maintenance of Already approved ANDAs – Annual Reports Submission, Review and approval of post approval changes. Reporting of Post approval Changes to FDA.
- Preparation , Maintenance and Training of Department SOPs
Candidate Profile:
B.Pharm /M.Pharm, preferably with some certification in Regulatory Affairs.
Additional Information:
Education : M.Pharm / B.Pharm
Location : Goregaon 12th Floor R-Tech Park Nirlon Complex, Off Western Express Highway Mumbai 400063
Functional Area: Corporate Regulatory Affairs
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