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Biotechnology Regulatory Expert
2 weeks ago
We are a leading biotechnology company at Immuneel Therapeutics Pvt. Ltd., working towards a common goal of delivering innovative cell therapy solutions to patients in India.
We are seeking an experienced Biotechnology Regulatory Expert to join our team and contribute to our mission of developing and delivering high-quality engineered cell therapies.
The ideal candidate will have a strong background in biotechnology, with experience in handling regulatory submissions, liaison with regulatory offices, and building relationships with key stakeholders.
This includes:
- Regulatory operations and liaison: Review and submit regulatory documents, including Test licence No C, Import licence, IND and MA applications for cell and gene therapy products to CDSCO.
- Representing the company for discussions and application with DCGI office, New Delhi.
- Submission and follow-up of RCGM submissions like form C3, Form C5 and liaison with RCGM and other ministries for meeting and approvals.
The successful candidate will have a deep understanding of Indian regulatory requirements, including the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars issued by the CDSCO.
In addition, they will have knowledge of the entire drug development process, from preclinical research to post-marketing surveillance, as well as familiarity with clinical trial regulations, including Good Clinical Practices (GCP) and the New Drugs and Clinical Trials Rules, 2019.
We offer a competitive package, including a salary range of ₹15 lakhs to ₹25 lakhs per annum, depending on experience, along with comprehensive benefits and opportunities for growth and development.
