Freshers Drug Regulatory Affairs Specialist Job at Sam Global Biocare, Apply on Rasayanika
Drug Regulatory Affairs Specialist
Company: Sam Global Biocare
Location: Gurgaon, Delhi NCR
Experience: 0 – 3 Years
Education: B.Pharm or M.Pharm
Salary Range: ₹3,00,000 – ₹3,60,000 per annum
Key Responsibilities
-
Dossier Management: Coordinate with manufacturers and clients (distributors) for dossier preparation, review, and submission for product registrations across various markets.
-
Manufacturer Collaboration: Engage with both Indian and international manufacturers to explore partnership opportunities, assess product portfolios, and identify suitable markets for collaboration.
-
Regulatory Compliance: Ensure adherence to international drug regulatory guidelines and manage documentation such as COPP, COA, MSDS, EU-GMP, USFDA, and WHO-GMP.
-
Client Communication: Communicate effectively with clients (distributors) to understand registration timelines, product interests, certification requirements, and sample needs.
-
Documentation & Reporting: Maintain accurate records of regulatory submissions, correspondence, and approvals while supporting the business team with relevant technical and regulatory insights.
Qualifications & Skills
• Education: B.Pharm or M.Pharm with strong knowledge of global regulatory requirements (beyond CDSCO India).
• Proven understanding of international regulatory standards for pharmaceuticals.
• Excellent documentation, communication, and coordination skills.
• Detail-oriented, proactive, and capable of managing multiple regulatory submissions simultaneously.
Benefits & Compensation
• Competitive salary: ₹3,00,000 – ₹3,60,000 per annum
.• Opportunity to work on international regulatory projects.
• Exposure to diverse global markets and regulatory systems.
Keywords: Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more. Freshers Drug Regulatory Affairs Specialist Job at Sam Global Biocare, Apply on Rasayanika.
