Cipla - Regional RA - Vikhroli

Cipla; Mumbai; Hybrid; INR 900,000 - 1,400,000; Full time

Job summary

Cipla in Mumbai seeks a Regulatory Affairs professional to drive timely dossier submissions, DMF management, and deficiency responses to regulatory authorities to enable product launches within agreed timelines.

You will coordinate with cross-functional teams and external stakeholders for query discussions, create DMF master records in LOA software, issue LOAs and CEPS, and verify pre-approved documents for accuracy and completeness.

Responsibilities

• Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
• Co-ordinate with cross-functional teams and external stake-holders for query response discussion and distribute updated work plan
• Create DMF master in LOA software & issue LOAs/CEPs
• Verify pre-approved documents
• Leverage product gap analysis #Preparation compilation and submission of the dossier documents I deficiency responses to agency as per the region specific requirements(for Para-IV -US) Preparation of MI documents, and collate the dossier/ deficiency responses package/DMF received from CDT and submit to the regulatory authority/customer
• Submit online audit dossier/DMF dong with queries

Job description

Key Accountabilities

Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time

• Co-ordinate with cross-functional teams and external stake-holders for query response discussion and distribute updated work plan
• *Create DMF master in LOA software & issue LOAs/CEPs
• Verify pre-approved documents
• Leverage product gap analysis #Preparation compilation and submission of the dossier documents I deficiency responses to agency as per the region specific requirements(for Para-IV -US) Preparation of MI documents, and collate the dossier/ deficiency responses package/DMF received from CDT and submit to the regulatory authority/customer
• Submit online audit dossier/DMF dong with queries