Dra Executive

Medicef Pharma; Solan; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

Canteen

Health insurance

Transport facility

Job summary

Medicef Pharma in India seeks a Regulatory Affairs professional to drive CTD/eCTD dossier preparation and submission for domestic and global markets.

You will coordinate with CDSCO, USFDA, EMA, and WHO, and compile DMF, ANDA, and MAA documents while supporting audits and handling regulatory queries in collaboration with cross-functional teams.

Qualifications

• Prepare and submit CTD/eCTD dossiers for domestic and global markets
• Coordinate with regulatory authorities (CDSCO, USFDA, EMA, WHO)
• Compile and review technical documents (DMF, ANDA, MAA)

Responsibilities

• Preparation (CTD/eCTD) of dossiers and submissions
• Coordination with regulatory authorities (CDSCO, USFDA, EMA, WHO)
• Review and compilation of DMF, ANDA, MAA documents
• Handling regulatory queries and variations
• Maintenance and compliance activities
• Support for audits and inspections
• Liaise with cross-functional teams to align regulatory strategy

Skills

CTD/eCTD prep

Regulatory liaison

Cross-functional coordination

Job description

• Preparation (CTD/eCTD)
• Coordination (CDSCO, USFDA, EMA, WHO)
• Review and Compilation of (DMF, ANDA)
• Handling Regulatory Queries and Variations
• Maintenance and Compliance
• Support for Audits and Inspections
• Liaise with Cross-Functional Teams

Required Candidate profile

• Prepare and submit CTD/eCTD dossiers for domestic and global markets
• Coordinate with regulatory authorities (CDSCO, USFDA, EMA, WHO)
• Compile and review technical documents (DMF, ANDA, MAA)

Perks and benefits

• Canteen
• Health insurance
• Transport facility