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Regulatory Affairs Manager
1 week ago
At Immuneel Therapeutics Pvt. Ltd., we are pioneering a new era in cell therapy and personalized immunotherapy for patients in India.
We are seeking an experienced Regulatory Affairs Manager to join our team and contribute to our mission of delivering high-quality engineered cell therapies.
The ideal candidate will play a critical role in managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational efficiency in regulatory processes.
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.
