Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop 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.
Post : Senior Research officer (Regulatory Affairs)
Emoluments : Rs.80,000 per month consolidated for a period of six months.
Location : CDSA, Faridabad
Job profile
• Coordinate and work closely with all the niche centres and members of the Regulatory Working Cell (DCGI, DBT, ICMR etc.)
• Assist the members of the Regulatory Cell by conducting background research and preparing background documents pertaining to relevant regulatory policies and guidelines both nationally and internationally on different subject areas as advised by the Regulatory Working Cell.
• Ability to conduct situational analysis/gap analysis of the Indian Regulatory space and be able to present the findings (through power-point presentations/other means) in a coherent manner.
• Assist with all internal/external communications as required.
• Any other activities such as organizing meetings/conferences as may be required by the Regulatory Working Cell.
Qualifications and Experience
Essential
• MD / PhD in Pharmacology from a recognized medical college/ University.
Desirable
• Knowledge of the Indian Regulatory space (DCGI, CDSCO, pharmaceutical companies etc.) or any previous experience in working with them.
Age limit
Not exceeding 40 years
Skills
• Effective communication skills,
• the provision of timely and accurate information to stakeholders
• Understanding of GCP, regulations and guidelines
• Fair and ethical.
• Ability to synthesize information from multiple sources and present the findings
• Excellent written and verbal communication skills in English
• Business computer skills (MS Word, Excel, e-mail)
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GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public-Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please send their current CV (Resume) along with the application form (attached on CDSA website) with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Senior Research officer (Regulatory Affairs)” to cdsa_admin@thsti.res.in.
6. Email application without clear subject line and incomplete applications will be summarily rejected.
7. Only shortlisted candidates will be contacted for further discussion
8. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
9. This position is strictly project-based.
10. All results will be published on our website and all future communications will be only through email
11. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
12. This position will be based out of CDSA with frequent travel within Delhi NCR area. 13. Canvassing in any form will be a disqualification.
Those who are applied earlier need not apply again.
Note: In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website
CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
Department of Biotechnology, Ministry of Science & Technology, Govt. of India
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)
Recruitment Notice No. CDS/RN/07/SRO/2018
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