BRIC-Translational Health Science and Technology Institute (THSTI) is an Institute of the Biotechnology Research and Innovation Council, Department of Biotechnology, Ministry of Science & Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into products to improve human health.
Post : Senior Program Officer (Regulatory Affairs)
This recruitment is to fill up the vacancies for project positions at Clinical Development Services Agency (CDSA) center. CDSA is a niche center of THSTI established to facilitate development of affordable healthcare products for public health diseases. It is the only public Centre in the country created with a mandate to support and nurture cost-effective, high quality, not-for-profit technology-based preclinical and clinical product development as well as support clinical research conducted by public agencies. It works towards development of an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.
Name of the Project : Indian Regulatory Science Course Development Support
Emoluments : Rs. 1,75,000/-
Age : Not exceeding 55 years
Educational Qualification and Experience :
• Post graduate degree in Pharmacology or Regulatory science or a related field
Essential Experience : • Minimum 8 years of professional experience in regulatory science, product development, clinical trials, or related fields
• Deep understanding of Indian regulatory frameworks (e.g., NDCT 2019) and international standards.
• Proven track record of collaborating with government bodies, academic institutions, and industry stakeholders
Job profile
CDSA-THSTI seeks a dynamic professional to spearhead the development of a Regulatory Science Curriculum for a Diploma program aimed at addressing India's evolving needs in regulatory science and clinical research. The position involves liaising with the Central Drugs Standard Control Organization (CDSCO), organizing workshops, and driving capacity-building initiatives to strengthen India's regulatory science ecosystem.
Key Responsibilities :
1. Regulatory Science program
• Curriculum Development: Design a comprehensive regulatory science diploma curriculum that incorporates both Indian regulations and global frameworks (e.g., US FDA, EMA, ICH guidelines).
• Stakeholder Collaboration: Act as the liaison between regulatory experts, academic institutions, and industry leaders to align the curriculum with current regulatory challenges and best practices. Coordinate and work closely with all the niche centers and members of the Regulatory Landscape in India (DCGI, DBT, ICMR etc.)
2. Workshop Leadership: Organize 2-3 high-impact workshops focused on critical topics such as regulatory strategies for product development, cGMP, etc.
3. Regulatory Support for Clinical Trials
• Review and advise on clinical trial applications (CTAs) for submission to the Central Drugs Standard Control Organization (CDSCO) and any queries from regulatory bodies.
• Resolve queries in regulatory science received to CDSA-THSTI from academic investigators and SMEs’.
• Develop a comprehensive repository of regulatory updates in CDSA DMS system for use by other stakeholders
4. Teaching and Capacity Building.
• Serve as a faculty member for MSc Clinical Science course and postgraduate diploma program in regulatory science.
• Design and deliver training sessions and workshops for internal teams and external stakeholders.
• Participate in relevant workshops, conferences, and training programs to enhance expertise
Skills
• Comprehensive knowledge of clinical trial and regulatory processes.
• Proficiency in tools and software for regulatory submissions and documentation.
• Effective team collaboration and stakeholder management skills.
• Strong organizational abilities to manage competing priorities and deadlines.
• Ability to analyze and synthesize complex information from diverse sources.
• Exceptional written and verbal communication skills, with a strong focus on detail and accuracy
• Demonstrated capacity to mentor and educate in the field of regulatory science
NOTE :
1) The candidates must bring their latest resume, one set of photocopy of documents in support of their educational qualification and experience along with originals and a valid ID cards for verification.
2) Candidates coming after the time slot mentioned will not be entertained.
3) All the candidates coming for written test/skill test/interview will be mandatorily required to deposit their mobile phone along with a valid Identity proof at the reception and the same will only be returned back on completion of the entire selection process.
General Terms & Conditions
a) These are the short-term positions and extension will be granted subject to satisfactory performance of the incumbents and tenure of the project for which they are selected. Those appointed to these positions will not have any claim for regularization of their employment.
b) All educational, professional and technical qualification should be from a recognized Board/University.
c) The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post. The candidates are required to satisfy themselves, before applying /appearing for the selection process, that they possess the minimum eligibility criteria as laid down in the recruitment advertisement. No query will be entertained with regard to the eligibility criteria.
d) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification, experience etc.
e) The age limit, qualification, experience and other requirements may be relaxed at the discretion of the competent authority, in case of candidates who are otherwise suitable.
f) Age and other relaxations for direct recruits and departmental candidates: 1. By five years for candidates belonging to SC/ST communities. 2. By three years for candidates belonging to OBC communities. 3. For Persons with Benchmark Disabilities (PwBD) falling under the following categories : (i) UR - ten years, ii) OBC - 13 years (iii) SC/ST - 15 4. Age is relaxable for Central Government servants up to five years in accordance with the instructions or orders issued by the Central Government, from time-to-time. 5. Institute employees will get the age relaxation to the extent of the service rendered by them as on closing date of advertisement. 6. For Ex-servicemen upto the extent of service rendered in defence forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service.
g) All results/notifications will only be published on our website. Therefore, the candidates should essentially visit THSTI website, regularly.
h) All communications will only be made through email.
i) In case a large number of applications are received, screening will be done to limit the number of candidates to those possessing higher/relevant qualification and experience.
j) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview.
k) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules/ guidelines shall prevail.
l) Canvassing wrong information in any form will be a disqualification.
Interested candidates fulfilling the criteria as mentioned above may walk-in for written test/skill test/interview at 9:00 am, on 13 June 2025 at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
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