KOLKATA

Responsibility

A Regulatory Affairs Specialist's involves ensuring a company's products and operations comply with relevant regulations, laws, and guidelines. Responsible for monitoring regulatory changes, preparing and submitting documents to regulatory agencies, and providing guidance to internal teams on compliance. This role also includes assessing compliance, recommending remediation, and acting as a liaison between the company and regulatory agencies. Responsible for preparing and submitting various documents, including product registration dossiers, clinical trial documentation, Endorsement approval COPP product wise approval and other regulatory submissions. Co-ordination for external audit with external Regulatory Agency with Regularity guideline awareness.

Qualifications

Minimum B. Pharm/M pharm/MSc. (M.PHARM preferable)

Job Summary

Published On:24/09/26

Vacancy





Required Skill:Regulatory Affairs roles require a blend of technical and soft skills. Solid analytical and problem-solving abilities are crucial for interpreting regulations and addressing complex issues. Effective communication, including writing and presentation skills, is essential for interacting with regulatory bodies and internal teams. Additionally, strong skills are needed to coordinate submissions and ensure compliance with deadlines

Location:KOLKATA

Dead Line

Company Detail

Mendine has always been a pioneer in development of oral liquid formulations, with its team of researchers and scientist along with most sophisticated instruments it has pioneered in oral liquid dosage forms which include solutions, syrups, suspensions, elixirs and concentrates.

📌 REGULATORY AFFAIRS SPECIALIST - RESEARCH & DEVELOPMENT - KOLKATA
🏢 Mendine Pharmaceuticals
📍 Kolkata