Regulatory Affairs Consultant
3 days ago
At Immuneel Therapeutics Pvt. Ltd., we are a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India.
Company OverviewWe pursue, with purpose, to serve our patients by connecting within, collaborating globally and creating solutions. Our flexible, diverse, and vibrant team brings together best practices and innovations in the field of cell and gene therapy.
About the RoleThis role requires strong organizational skills, a high level of attention to detail, and the ability to collaborate across cross-functional teams. 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.
Main Responsibilities- 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.
- Represent immuneel for discussions and application with DCGI office, New Delhi.
- Submission and follow up of RCGM submissions like form C3, Form C5 and liaise with RCGM and for meeting and approvals.
The ideal candidate should have 10+ years of experience in regulatory operations, regulatory affairs, or a related field. They should also have extensive experience in liaison with DCGI, RCGM and other regulatory offices. Additionally, they should possess strong soft skills, including excellent communication and negotiation skills, technical writing skills, and presentation skills.
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