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

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

Soft Skills: Meticulous attention to detail, robust 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).

📌 Regulatory Affairs Executive Mumbai (India)
🏢 Medi Pharma Drug House
📍 India