Regulatory Affairs Executive

Medi Pharma Drug House; Mumbai City; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Medi Pharma Drug House is seeking a Regulatory Affairs Executive to manage preparation, compilation, and submission of regulatory documents for product approvals. The role involves monitoring global guidelines, addressing inquiries, and maintaining SOPs to ensure compliant filings.

Ideal candidates have 2–5 years of hands‑on regulatory affairs experience, a B.Pharm/M.Pharm/D.Pharma, and a diploma/certification in Regulatory Affairs. Proficiency with DMS and MS Office is appreciated.

Qualifications

• Bachelors or Masters in Pharmacy (B.Pharm / M.Pharm / D.Pharm) is compulsory.
• Post-graduate diploma or certification in Regulatory Affairs is highly advantageous.
• 2–5 years of hands‑on regulatory affairs experience within a regulated industry.

Responsibilities

• Dossier compilation: Prepare, review, and submit high-quality regulatory documents for customer approval.
• Compliance tracking: Monitor national and international guidelines (FDA, EMA, CDSCO, ICH) to ensure compliance across product documents.
• Agency liaison: Serve as the primary contact for customer inquiries and address technical deficiencies.
• Cross-functional collaboration: Build relationships with suppliers and manufacturers for regulatory documents per SOP.
• Maintenance: Draft and update SOPs to keep internal regulatory filing operations compliant.

Skills

Regulatory affairs

Document Management System

Documentation

MS Word

MS Excel

Education

B.Pharm / M.Pharm / D.Pharm

Regulatory Affairs certification/diploma

Tools

Document Management System (DMS)

Job description

Job Purpose:

• The Regulatory Affairs Executive manages the preparation, compilation, and of regulatory documents to secure and maintain product marketing approvals.
• Checking of certificate of analysis (COA) as per updated monograph
• This role coordinates cross-functionally to ensure compliance with changing global guidelines while minimizing approval timelines.

Key Responsibilities:

• Dossier Compilation: Prepare, review, and submit high-quality regulatory documents for customer approval.
• Compliance Tracking: Monitor national and international guidelines (like FDA, EMA, CDSCO, or ICH) to guarantee complete compliance across product documents.
• Agency Liaison: Serve as a primary point of contact for customer inquiries and systematically address technical deficiencies.
• Cross-Functional Collaboration: Build relationships with Suppliers & Manufacturers for asking regulatory documents as per SOP.
• Maintenance: Draft and update standard operating procedures (SOPs) to keep internal regulatory filing operations compliant.

Educational Qualifications Required Degree:

• Bachelors or Master's degree in Pharmacy (B.Pharm / M.Pharm/D.pharm) - Compulsory
• Post-graduate diploma or certification in Regulatory Affairs is highly advantageous

Skills & Experience

Professional Experience: 2 to 5 years of hands‑on regulatory affairs experience within a regulated industry.

Soft Skills: Meticulous attention to detail, strong problem‑solving capabilities, and crisp written and verbal communication.

Tool Proficiency: Experience with Document Management Systems (DMS) and standard office productivity suites (MS Word, Excel).