Tejendra cv dra
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Tejendra Singh Sirohi is seeking a challenging position in regulatory affairs with a growth-oriented company. He has over 2 years of experience as a Regulatory Affairs Executive and Officer QA. His responsibilities have included dossier preparation and submission, responding to queries from drug authorities, and reviewing documentation for product registrations and renewals. He is proficient in Indian regulatory requirements and has skills in drafting various administrative documents, compiling drug dossiers, and liaising with regulatory authorities. He holds an M.Pharma in Pharmaceutical Chemistry and B.Pharma degree.
![ Liaison with DCGI office,New Delhi and other state FDA likeChandigarh & Haryana.
Review of Technical Data - BMR, BPR, BPCR, Stability data- Real-timeand Accelerated stability,COA,
Adverse events report, CAPA, Shelf-Life report of different Products.
Intellectual Property Rights (IPR).
Proficientin computer handlingand well versed with Windows and its applicationslikeMS Office (Word,
Excel, and Power point), Paint,Adobe reader, Internet Explorer & other browser as well.
EDUCATIONAL QUALIFICATION
Year Degree Institute/ School Board/ University Marks/
Grade
2010-12 M.Pharma
(Pharmaceutical Chemistry)
Dr. K. N. Modi Institute of
Pharmaceutical Education &
Research, Modinagar
MTU, Noida 79.10 %
2006-10 B.Pharma R.R.S College of Pharmacy,
Amethi
UPTU, Lucknow 66.65 %
2003-05 Intermediate (10+2th) New Standard Public
School, Raebareli
UP Board,
Allahabad
76.40 %
2001-03 High School (10th) New Standard Public
School, Raebareli
UP Board,
Allahabad
59.00 %
Other Certification & Courses
2003 Computer Certification Web Computers, Raebareli Affiliated from
U.P. Govt.
A
2013 General Course on
Intellectual Property
WIPO Academy WIPO,Geneva Successfully
completed
PROJECT WORK
Synthesis & Biological Evaluation of 1,2,4 Triazine derivatives (submitted in M.Pharma).
Phytochemical Evaluation on The Ethanolic Leaf Extract of Plant Azadirachta indica (submitted in
B.Pharm).
PUBLICATIONS
Design, synthesis and anticonvulsantactivity of some new 5,7-dibromoisatin semicarbazonederivatives,
EXCLI Journal, 2013.
1,2,4-TriazineAnalogs as Novel Class of Therapeutic Agents, Mini-Reviews in Medicinal Chemistry, 2014.
Design, Synthesis and AnticonvulsantActivity of Some New 6,8-Halo-substituted-2H[1,2,4] Triazino [5,6-B]
Indole-3(5H)-One/- Thione and 6,8-Halo-Substituted 5-Methyl-2H-[1,2,4] Triazino [5,6-B] Indol- 3(5H)-
One/-Thione, EXCLI Journal, 2014.
PERSONAL INFORMATION
Father’s Name : Mr. Rajkiran Singh Sirohi
Date of birth : 02-05-1989
Sex : Male
Marital status : Unmarried
Languages known : English and Hindi
Permanent Address : 279, Udaipur,Thana-Babugarh,Hapur-245101,Uttar Pradesh.
I hereby declarethat the details mentioned above are true and I shall furnish the necessary certificates whenever
required.
Date:
Place: New Delhi TEJENDRA SINGH SIROHI](https://image.slidesharecdn.com/ovturr2r2rf4j4un3ytq-signature-781dcc7b8ea94971c369b97a1533a297fe626039fedafd93999cdb0aa0b0810b-poli-150210004444-conversion-gate02/85/Tejendra-cv-dra-2-320.jpg)
Tejendra cv dra
- 1. TEJENDRA SINGH SIROHI tejendra.sirohi@gmail.com in.linkedin.com/pub/tejendra-sirohi/23/316/6a CARRIER OBJECTIVES To firmly establish myself in a challenging position with a growth & performance oriented company that will ultimately lead to a well known top position in the field of Drug Regulatory Affairs. SUMMARY Experienced Regulatory Affairs (RA) professional who wants to influence own development & always ready to take initiative and keen to learn new concepts. I believe in 100 % dedication, determination and desire to whatever work been undertaken by me. PROFESSIONAL EXPERIENCE - 2 Year and 4 Months March 2013 to Current Regulatory AffairsExecutive Company Name: Accredited Consultants Pvt. Ltd., New Delhi. Company Profile: Complete regulatory service& assistanceprovider for licensingof Pharma/ Medical Device Companies for their products likeFinished Dosage,API, Cosmetics, Biologicalsand Medical Devices & Diagnostic kits (www.acplgroupindia.co.in) Role & Responsibility: 1. Preparation, Compilation and Submission of CTD dossiers to DCGI, New Delhi or SLA on behalf of our leading clients (Indian Agents) & foreign manufacturers likeCR Bard, Roche Diagnostics & DSMSinochem. 2. Query response to the query letter issued by DCGI, New Delhi or other state licensingauthority. 3. Review of Change Notification or PostApproval Changes and its submission to CDSCO or various other Govt. authorities for already registered productor formulation with in stipulated timeline. 4. Co-ordination with other supportingdepartments of different Pharma/ Medical DeviceManufacturers for Data generation & regulatory authorities for registration of the products. 5. Maintain existinglicenses of our clients (Indian agents) and regular updation of tracker sheet. 6. Review of labels and artwork corrections as per Rule 96 of Drug & Cosmetic Act 1940. Sept 2012 to Feb2013 Officer QA Company Name: Samson Laboratories Pvt. Ltd. Solan,H.P. Company Profile: A Pharma contractmanufacturingcompany (www.samson.co.in). Role & Responsibility: 1. Preparation & issuanceof documents likeMFR, BPCR, SOPs, logbooks,etc. Maintain document masters for all critical documents.Maintain issuancerecords for all thedocuments. 2. Management of documentation control room and ensure proper labeling and segregation of documents for easy retrieval. KEY SKILLS Schedule M and GMP requirements for Drugs, Cosmetics and Medical Devices. NDA, ANDA filingfor registration of product in India. Efficient in draftingall administrative& legal documents likeCovering Letter, Application Forms (Form 8, Form 12, Form 40, Form 42 etc.), schedule-DI,DII, DIII,Power of Attorney, TR Challan (for Govt. Fee), different undertaking for various applications and query responseas well. Efficient in draftingapplication for manufacturingpermission of bulk drugs (i.e., API) on the basis of export NOC received from CDSCO’s North Zone Office,Ghaziabad & its submission to state licensing authority likeState Drug Controller/ Asst. Drug Controller,Chandigarh & Panchkula. Compilation and review of Drug Master File(DMF), PMF, PMS, CAPA, FSCA within dossiers for registration and renewal as per applicableIndian regulatory requirements & rules.
- 2. Liaison with DCGI office,New Delhi and other state FDA likeChandigarh & Haryana. Review of Technical Data - BMR, BPR, BPCR, Stability data- Real-timeand Accelerated stability,COA, Adverse events report, CAPA, Shelf-Life report of different Products. Intellectual Property Rights (IPR). Proficientin computer handlingand well versed with Windows and its applicationslikeMS Office (Word, Excel, and Power point), Paint,Adobe reader, Internet Explorer & other browser as well. EDUCATIONAL QUALIFICATION Year Degree Institute/ School Board/ University Marks/ Grade 2010-12 M.Pharma (Pharmaceutical Chemistry) Dr. K. N. Modi Institute of Pharmaceutical Education & Research, Modinagar MTU, Noida 79.10 % 2006-10 B.Pharma R.R.S College of Pharmacy, Amethi UPTU, Lucknow 66.65 % 2003-05 Intermediate (10+2th) New Standard Public School, Raebareli UP Board, Allahabad 76.40 % 2001-03 High School (10th) New Standard Public School, Raebareli UP Board, Allahabad 59.00 % Other Certification & Courses 2003 Computer Certification Web Computers, Raebareli Affiliated from U.P. Govt. A 2013 General Course on Intellectual Property WIPO Academy WIPO,Geneva Successfully completed PROJECT WORK Synthesis & Biological Evaluation of 1,2,4 Triazine derivatives (submitted in M.Pharma). Phytochemical Evaluation on The Ethanolic Leaf Extract of Plant Azadirachta indica (submitted in B.Pharm). PUBLICATIONS Design, synthesis and anticonvulsantactivity of some new 5,7-dibromoisatin semicarbazonederivatives, EXCLI Journal, 2013. 1,2,4-TriazineAnalogs as Novel Class of Therapeutic Agents, Mini-Reviews in Medicinal Chemistry, 2014. Design, Synthesis and AnticonvulsantActivity of Some New 6,8-Halo-substituted-2H[1,2,4] Triazino [5,6-B] Indole-3(5H)-One/- Thione and 6,8-Halo-Substituted 5-Methyl-2H-[1,2,4] Triazino [5,6-B] Indol- 3(5H)- One/-Thione, EXCLI Journal, 2014. PERSONAL INFORMATION Father’s Name : Mr. Rajkiran Singh Sirohi Date of birth : 02-05-1989 Sex : Male Marital status : Unmarried Languages known : English and Hindi Permanent Address : 279, Udaipur,Thana-Babugarh,Hapur-245101,Uttar Pradesh. I hereby declarethat the details mentioned above are true and I shall furnish the necessary certificates whenever required. Date: Place: New Delhi TEJENDRA SINGH SIROHI