Latest Biotech Jobs At Immuneel | Apply Now For The Analyst / Specialist – Regulatory Affairs Role
Immuneel Therapeutics Pvt. Ltd. is hiring an Analyst / Specialist in Regulatory Affairs (CMC and Operations) at its Bengaluru office. This exciting full-time role offers professionals the opportunity to work at the forefront of cell and gene therapy, ensuring regulatory excellence in a dynamic, purpose-driven environment. Ideal for candidates with 2–5 years of experience in CMC and regulatory operations.
- Job Position: Analyst / Specialist – Regulatory Affairs (CMC and Operations)
- Location: Bengaluru, Karnataka
About Immuneel Therapeutics
Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India and the world. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. We are proud to be an organization that values diversity, work-life balance, and fostering a collaborative environment for the mutual growth of our employees and the company. Join us in our mission to drive patient outcomes and make a difference in healthcare.
Job Description
This individual contributor role supports global regulatory submissions and ensures compliance with all applicable guidelines. You will
engage with cross-functional teams and regulatory bodies, making significant contributions to Immuneel’s mission in engineered cell and gene therapy.Key Responsibilities for Latest Biotech Jobs At Immuneel
Regulatory CMC and Operations
- Prepare, review, and submit regulatory applications (e.g., Clinical Trial Applications, IND, MA, Test Licence NoC, Import Licences, IMPD) to CDSCO and other regulatory bodies.
- Submit forms (Form B1, C3, C5) and documentation to RCGM; manage KDCD submissions (Form 27, Form 30, WHO GMP, COPP).
- Coordinate with IBSC/GTAEC and respond to regulatory queries.
- Handle online submissions on RCGM, SUGAM, and NSWS portals.
- Familiarity with CTD/eCTD (Modules 1–5) and ACTD (Parts I–IV) formats.
- Ensure compliance for lifecycle management activities and participate in audits.
- Government Affairs
- Liaison with CDSCO, KDCD, RCGM, and IBSC Committees.
- Establish and manage working relationships with regulatory bodies.
- Regulatory Intelligence
- Stay current on Indian and global regulatory frameworks for Biologics and CGT products.
- Track developments and competitive intelligence in CGT, sharing insights with internal teams.
Qualifications
Education:
-
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
Experience:
- 2–5 years in Regulatory Affairs (CMC and Operations).
- Proven experience handling submissions to DCGI, RCGM, KDCD, etc.
Keywords: Analyst, Latest Biotech Jobs At Immuneel, Specialist, Regulatory Affairs, CMC, Operations, Immuneel Therapeutics, Bengaluru, Karnataka, India, Life Sciences jobs, Pharmacy, Biotechnology
