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Regulatory Compliance Specialist
1 week ago
At Immuneel Therapeutics Pvt. Ltd., we are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our regulatory operations department, you will play a critical role in ensuring compliance with global regulatory requirements.
The ideal candidate will have a strong understanding of the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars issued by the CDSCO. You will be responsible for reviewing and submitting regulatory documents, including Test licence No C, Import licence, IND and MA applications for cell and gene therapy products.
In addition to your technical expertise, you will possess excellent communication and negotiation skills, allowing you to effectively interact with CDSCO officials and build rapport. Your ability to analyze complex regulatory requirements and identify potential challenges will be essential in finding solutions to regulatory issues.
We offer a dynamic and collaborative work environment where you can excel and find purpose. Our team is passionate about driving patient outcomes and making a meaningful impact in the field of cell and gene therapy.
