Regulatory Affairs Executive

Accuprec Research Labs; Ahmedabad District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Accuprec Research Labs is seeking a Regulatory Affairs professional with M.Pharm (Reg. Affairs) to lead global submissions and dossier preparation. The role focuses on CIS/EAEU market submissions and regulatory coordination across functions.

You will maintain SMF and GMP documentation, perform gap analysis, monitor regulatory updates, and collaborate with R&D, QA, and Production to ensure compliance and timely filings.

Qualifications

• Hands-on experience in global submissions (CIS/EAEU markets).
• Dossier preparation and regulatory coordination.
• Compliance management and regulatory coordination across functions.

Responsibilities

• Prepare and submit CTD/eCTD dossiers as per regulatory requirements
• Manage EAEU Unified Registration submissions
• Maintain Site Master File (SMF) and GMP documentation
• Perform gap analysis and ensure dossier compliance
• Track regulatory updates and global guidelines
• Coordinate with R&D, QA, and Production teams

Skills

Global submissions

Dossier prep

Compliance management

Regulatory coordination

CIS/EAEU markets

Education

M.Pharm (Reg. Affairs)

Job description

M.Pharm (Reg. Affairs)

Hands-on experience in global submissions (CIS/EAEU markets), dossier preparation, compliance management, and regulatory coordination.

Key Responsibilities

• Prepare and submit CTD/eCTD dossiers as per regulatory requirements
• Manage EAEU Unified Registration submissions
• Maintain Site Master File (SMF) and GMP documentation
• Perform gap analysis and ensure dossier compliance
• Track regulatory updates and global guidelines
• Coordinate with R&D, QA, and Production teams