Salary: ₹1,75,000 per month
Age Limit: Up to 55 years
Last Date to Apply: Walk-in Interview on 13 June 2025
About CDSA-THSTI
The Translational Health Science and Technology Institute (THSTI) is a premier institute under the Biotechnology Research and Innovation Council (BRIC), Department of Biotechnology, Government of India. Located in Faridabad, THSTI focuses on translational research to develop affordable healthcare solutions.
The Clinical Development Services Agency (CDSA) is a specialized center under THSTI that supports clinical research, regulatory affairs, and product development for public health. It plays a crucial role in fostering collaborations between government bodies, academia, and SMEs to accelerate medical innovations.
Job Description: Senior Program Officer (Regulatory Affairs)
Educational Qualification & Experience
- Postgraduate degree (MPharm/MSc) in Pharmacology, Regulatory Science, or related fields.
- Minimum 8 years of experience in regulatory affairs, clinical trials, or product development.
- Strong knowledge of Indian regulatory frameworks (NDCT 2019, CDSCO guidelines) and global standards (US FDA, EMA, ICH).
- Experience in stakeholder collaboration, curriculum development, and regulatory submissions.
Key Responsibilities
- Regulatory Science Program
- Develop a Diploma in Regulatory Science curriculum aligned with Indian and global regulations.
- Collaborate with CDSCO, DBT, ICMR, and industry experts to enhance regulatory training.
- Workshop Leadership
- Organize 2-3 workshops on regulatory strategies, cGMP, and clinical trial compliance.
- Regulatory Support for Clinical Trials
- Review Clinical Trial Applications (CTAs) for CDSCO submissions.
- Address regulatory queries from investigators and SMEs.
- Maintain a regulatory updates repository in CDSA’s DMS system.
- Teaching & Capacity Building
- Serve as faculty for MSc Clinical Science & Regulatory Science Diploma programs.
- Conduct training sessions for researchers and industry professionals.
Required Skills
✔ Expertise in regulatory submissions & clinical trial processes.
✔ Strong communication, leadership, and stakeholder management skills.
✔ Ability to mentor professionals in regulatory science.
✔ Proficiency in regulatory documentation software.
How to Apply?
- Walk-in Interview Date: 13 June 2025
- Reporting Time: 9:00 AM
- Venue:
THSTI, NCR Biotech Science Cluster,
3rd Milestone, Faridabad-Gurugram Expressway,
Faridabad – 121001
Documents Required:
- Latest resume
- Photocopies of educational & experience certificates
- Original documents for verification
- Valid ID proof (Aadhaar, PAN, Passport, etc.)