Company Description Mendine Pharmaceuticals Pvt. Ltd., founded in 1937 in Kolkata, West Bengal, is an ISO 9001:2008 and GMP/GLP certified manufacturer specializing in oral liquids, suspensions, and a broad range of pharmaceutical, nutraceutical, and food supplement products. The company focuses on discovering, developing, and marketing innovative therapies that prevent and treat diseases while improving quality of life.

Mendine operates from its registered office in Alipore, Kolkata, with a manufacturing facility in Mahestala and branches across several Indian cities, employing approximately 450 team members. The organization is committed to enhancing health outcomes for all stakeholders through effective, patient-centric products and brands.

Role Description This is a full time, on-site Regulatory Affairs Specialist role based in India. The specialist will prepare, review, and maintain regulatory documentation and dossiers for pharmaceutical, nutraceutical, and food supplement products in accordance with national and international guidelines. Day-to-day responsibilities include coordinating regulatory submissions, tracking approvals, ensuring ongoing regulatory compliance, and supporting product lifecycle management.

The role involves interpreting regulatory requirements, advising cross-functional teams (such as R&D;, quality,



and manufacturing), and participating in audits and inspections. The specialist will also monitor regulatory changes, update internal processes, and contribute to continuous improvement of Mendine’s compliance framework.

Qualifications

- Candidates should possess strong skills in Regulatory Documentation and dossier preparation.
- Candidates should possess thorough knowledge of Regulatory Requirements and applicable guidelines for pharmaceutical and related products.
- Candidates should possess experience in Regulatory Affairs and regulatory strategy within the pharmaceutical or healthcare industry.
- Candidates should possess proven capability in managing Regulatory Submissions and tracking approvals with relevant authorities.
- Relevant bachelor’s or master’s degree in Pharmacy.
- Understanding of GMP/GLP standards, quality systems, and product lifecycle management.
- Strong analytical, documentation, and organizational skills with attention to detail.
- Effective written and verbal communication skills and ability to collaborate with cross-functional teams.
- Prior experience with Indian regulatory authorities; exposure to international regulatory environments is an advantage.

📌 Regulatory Affairs Specialist (India)
🏢 Mendine Pharmaceuticals
📍 India