Immuneel Therapeutics is a leading Indian biotech startup specializing in cell and gene therapies for cancer treatment. With a mission to deliver personalized immunotherapy, Immuneel combines cutting-edge science with a collaborative, patient-first approach. The company fosters a flexible, diverse, and vibrant work culture, emphasizing innovation, accountability, and work-life balance.
Job Title: Analyst / Specialist – Regulatory Affairs (CMC & Operations)
📍 Location: Bengaluru, Karnataka (On-site)
🕒 Job Type: Full-time
🎓 Experience: 2-5 years
Key Responsibilities:
✔ Regulatory Submissions: Prepare and file IND, IMPD, MA applications, CTAs, and other regulatory documents for CDSCO, RCGM, KDCD, and global agencies.
✔ Compliance & Liaison: Manage regulatory compliance, interact with CDSCO, RCGM, KDCD officials, and ensure adherence to D&C Act, GMP, and GCP guidelines.
✔ Documentation & Intelligence: Maintain CTD/eCTD/ACTD dossiers, track regulatory updates, and provide competitive intelligence on cell & gene therapies.
✔ Cross-functional Collaboration: Work with QA, R&D, and Clinical Teams to support audits and lifecycle management (LCM).
Eligibility & Skills:
✅ Education: B.Pharm/M.Pharm, MSc (Biotech/Life Sciences), or related field.
✅ Experience: 2-5 years in regulatory affairs (CMC + Operations), preferably in biologics/cell therapy.
✅ Technical Skills: Expertise in SUGAM, RCGM, CTD/eCTD submissions, and regulatory compliance.
✅ Soft Skills: Strong communication, negotiation, problem-solving, and attention to detail.
Why Join Immuneel?
✨ Innovative Work: Be part of India’s pioneering cell & gene therapy revolution.
✨ Inclusive Culture: Flat hierarchy, flexible work policies, and collaborative environment.
✨ Career Growth: Opportunities for skill development & leadership roles.
✨ Work-Life Balance: Rotational shifts with 2 weekly offs (not necessarily weekends).
How to Apply
📩 Email your resume to: careers@immuneel.com
📍 Office Address:
Immuneel Therapeutics Pvt. Ltd.,
8th Floor, Mazumdar Shaw Medical Center,
Narayana Health City, Bommasandra, Bangalore – 560099
