Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.

Post : Senior Research Officer (Regulatory Affairs)

Emoluments : Rs.80, 000 per month consolidated

Duration : six months, likely to be extended as per the requirement of the project.

Location : CDSA, Faridabad

Age : Not exceeding 45 years

Qualifications and Experience
Essential qualification:
MD /Ph.D. 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.

Job profile
• Coordinate and work closely with all the niche centers 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.

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. Only shortlisted candidates will be contacted for further discussion
6. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is actual and will be based on experience, qualifications, skill set, etc. of the candidates.
7. This position is strictly project-based.
8. All results will be published on our website and all future communications will be only through email
9. Candidates (Including SC/ST and other backward classes) are not entitled to the travel reimbursement or any other reimbursement.
10. This position will be based out of CDSA with frequent travel within Delhi NCR area.
11. Canvassing in any form will be a disqualification.

Procedure for filling online application:
a. Before filling up the online application, keep the following documents handy:
i) A soft copy of your passport size photo and signature. (Only jpeg/jpg format, file size 50 kb maximum)
ii) A comprehensive CV (PDF format only, file size 1 Mb maximum) containing details of qualification, positions held professional experience/distinctions, etc.
iii) The documents in support of educational qualification and experience (PDF format only, file size 1 Mb maximum) as mentioned below:
• Matriculation Mark sheet
• Intermediate Mark sheet
• Graduation Degree/Mark Sheet
• Post-Graduation Degree/Mark Sheet
• Ph.D. degree
• Relevant experience certificates
• Caste certificate in the format prescribed by the Govt. of India, if applicable
• Disability certificate in the format prescribed by the Govt. of India, if applicable
• List of Publications (if any)
• List of patents (if any) b. Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
c. Once the online application is submitted, no correction/ modification is possible.
d. In case of difficulty in filling up the online form, please send an e-mail to mahendersingh.cdsa@thsti.res.in
e. On successful submission of your application, an auto-generated email containing a reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence

Note: In case a suitable candidate is not found, the call for application will remain open until a suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.

CLINICAL DEVELOPMENT SERVICES AGENCY
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)