Regulatory Affairs Professional
2 days ago
About Immuneel Therapeutics Pvt. Ltd.
At Immuneel, we're pioneering a new frontier in cell therapy and personalized immunotherapy for patients in India. Our mission is to pursue excellence, serve our patients with purpose, and connect globally. We value diversity, work-life balance, and an open environment where everyone can thrive.
We're looking for a talented professional to join our team as a Regulatory Affairs Specialist. As a critical member of our regulatory operations team, you'll play a key role in managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational efficiency.
Key Responsibilities:
- Review and submit regulatory documents, including Test licence NoC, Import licence, IND and MA applications for cell and gene therapy products
- 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
- Liaise with ICMR, BIRAC and any other assigned allied departments for the regulatory process of the cell and gene therapy products
- Expertise in handling the online submissions of RCGM/SUGAM/NSW portals
- Follow up of regulatory applications with CDSCO and RCGM
- Governance Liaison with Ministries and secretariats like Department of Biotechnology, Department of Pharmaceuticals, Ministry of Health, Ministry of finance and Ministry of Commerce and other ministries and secretariats as assigned
Qualifications:
- Educational Qualification: Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or a related field
- Experience: 10+ years of experience in regulatory operations, regulatory affairs, or a related field
Working Conditions:
- Role Type: Full Time
- Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis)
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