Regulatory Affairs Executive

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).