REGULATORY AFFAIRS JOBS DELHI : ARHAM CONSULTANTS

[Admin]

ARHAM CONSULTANTS PITAMPURA DELHI : FEMALE EXECUTIVE,REGULATORY AFFAIRS
Company Name : ARHAM CONSULTANTS
Company Location : PITAMPURA DELHI
Designation (of vacancy) : FEMALE EXECUTIVE,REGULATORY AFFAIRS
Company E-mail ID : bombaytc@yahoo.co.in
Company Website : arhamconsultants.com

Job Description, Candidate Profile, Company Profile, Company Address :
Job Description :
1. Preparation & Review of Registration Dossiers of pharmaceutical formulations for CIS, US , European & Indian markets.
2. Re-presentation of scattered company information in CTD Module details.
3. Preparation of product Justifications for new formulations/products
4.Should hold a membership of Pharmacy Council of Delhi
5.Minimum 1-2 Years of QA-QC / Dossiers preparation Experience.
6.Must be Proficient in MS Office Computer skills

Address :
35 Veer Nagar, Rana Pratap Bagh,
Nr. G.T. Road Industrial Area, New Delhi-110007, India

[Guest]

COVER LETTER
Dear Sir/Madam,
The attached resume is presented to you for your contemplation regarding the post of Pharmaceutical Regulatory Affairs and I am post graduated from Manipal University with a degree of Master of Science in Pharmaceutical Regulatory Affairs.
As you can see in the enclosed resume, I have strong academic background in Pharmaceutical Regulatory Affairs with over four years in Bachelor of Pharmacy and 2 years in specialization i.e. Master of Sciences in Pharmaceutical Regulatory Affairs. My recent internship at Torrent Pharmaceuticals Ltd., India, allowed me to further develop and strengthen my technical skills in a dept. of Regulatory affair in Europe team.
As a specialization in Regulatory affairs, I am very much familiar with ICH, EU, USFDA, GMP, and Clinical Trials Regulations and also intellectual property rights.
Being a student of Manipal University I am confident that my combination of practical work experience and solid educational experience has prepared me for making an immediate contribution to big pharma companies.
I believe that I could make a significant and valuable contribution to your firm.
I would appreciate the opportunity to discuss how my education experience will be helpful you.
Thank you for your time and consideration.
CURRICULUM VITAE
SRIKANTH THALLAPALLY
(Master of Sciences in Pharmaceutical Regulatory Affairs)
E-mail ID : tskanth.ra AT gmail.com
srikanth.thallapally AT learner.manipal.edu
Professional Profile
I am competent, enthusiastic regulatory affairs professional, who strives to develop and successfully implement progressive strategies with regulatory awareness for effectively meeting the challenges of global regulatory environments. I find my growth in the growth of the organization.
Objective
To work as an efficient team player for a research organization in the field of Regulatory Affairs.
Professional Qualification
Qualification Institution University/Board Year %
Masters in Pharmaceutical Regulatory Affairs
Part-II
(PG) Manipal College of Pharmaceutical Science, Manipal. Manipal University 2010-11 Awaiting results.
Part – I
Manipal College of Pharmaceutical Science, Manipal. Manipal University
2009-10
71 %
B. Pharmacy
(UG) Vaagdevi College Of Pharmacy, Hanamkonda, Warangal ,A.P. Kakatiya University, Warangal
2006-09
72.4%
10+2
SN Junior College ,
Hanamkonda, Warangal. Board of Intermediate education, A.P 2003-05 79.8%
High School Scholars High School,
Warangal. Board of secondary education 2003
84.5 %
Areas of special interest
CTD filling, eCTD, ANDA, NDA, Dossier preparation for various Dosage Forms, Variations filing, DMF, Intellectual Property Rights., etc
Knowledge Areas
- Familiar with various Regulatory Guidelines (ICH, FDA, EMA, CDSCO etc.).
- Registration of New Drugs in EU & US.
- Common Technical Documents (CTD)-filing.
- Dossier preparation for various Dosage Forms.
- Electronic Submissions
- GMP regulations-India, WHO, US and Europe.
- Pre & Post Marketing Regulatory Requirements.
- Intellectual Property Rights.
- Clinical Trials & Regulations.
Seminars delivered
1. The Common Technical Document (CTD-filing) for the Registration of Pharmaceuticals for Human use.
2. Laboratory Bio Safety Levels.
3. IND and NDA Review.
4. Export of Bio-Samples.
5. Batch Release Documentation
6. Quality Audits
7. Analytical and Bioanalytical Method validation
8. Regulatory perspective of Anticancer drug development process for Europe & USA.
Dissertation work
In College :
I have completed my minor project as a part of M.Sc. curriculum during September 2010 to December 2010.
Title : “Current Scenario of Generic Drug Registration & Regulations in Brazil, Russia, India and China (BRIC) Countries”
Summary :
Detail study of the current regulations for Generic drugs and registration process in emerging markets like Brazil, Russia, India & China (BRIC) and highlighting the differences in BRIC countries
In Torrent Pharmaceutical Ltd. :
Title : “Regulatory Perspective of Anticancer Drug development process for EU and US”
Summary :
Detail explanation about the specific Anticancer drug regulations in drug development process begins with manufacturing site requirements (GMP), Bioequivalence study requirements, etc., and end with approval process with last five years of statistical analysis representation about approvals of USFDA and EMEA and EU member states.
Extracurricular Achievements
- Passed IPR-DL101 certificate course (November 2010), conducted by world intellectual properties organization (WIPO).
- Participated actively in Blood donation camps.
- Life time member of Indian Pharmaceutical Graduates Association (IPGA)
- Active member of scientific review committee for IPC (Indian Pharmaceutical Congress) 2010 held at MANIPAL in December 2010.
Poster presentation & Publications
- Presented Poster in 62nd IPC at Manipal on “WHO Prequalification Project- Good Quality Medicines for Everyone and a view on Indian Products”.
Publications :
- Srikanth.T*, Syed sajjad Hussen, Anand Abha, Vasantharaju SG. “A comparative view on cosmetic regulations : USA, EU and INDIA”. Scholars Research Library journal Der Pharmacia Lettre, 2011, 3(1): 334-34
- Srikanth.T*, Syed sajjad Hussen, Anand Abha, Vasantharaju SG. “Current Scenario of Generic Drug Registration & Regulations in Brazil, Russia, India and China (BRIC) Countries”. IJPSRR (Paper is communicated).

[nekkanti.narendra]

CURRICULUM VITAE
N.Narendra Prasad
Mail To : nekkanti.narendra AT gmail.com
I am seeking a position in a result oriented company that utilizes my competent technical skills towards continuous growth and advancement and provides a valuable learning experience.
- M.Sc (Chemistry) from Kuvemppu University in distance mode
- Passed out B.Sc (MPC)from Andhra university in 2006
- Passed out Intermediate (MPC) from Board of Intermediate in 2002.
- Passed out SSC from Board of Secondary Education in 2000.
- Presently working as a Quality control Senior Chemist in SMS Pharmaceuticals ltd(Unit-VII), is an API bulk Drugs at Kandivalasa village, Vizianagaram district. A.P from October-2010 to till date
- Previous worked as a Quality control Chemist in Divi’s Laboratories Ltd., is an API Bulk Drugs and FDA Division at Choutuppal,Nalgondadt (Unit-I) from to AUG- 2006 to October-2010.
- Analysis of Finished API, Intermediates, Raw materials by HPLC,GC-HS,U.V, IR
- Calibrations of HPLC ,GC-HS U.V , I.R
- Analysis of Stability samples by HPLC
- Residual solvents & Purity by GC
- Analytical method validations By HPLC,
- In process samples testing.
- HPLC _Assay , Related substances , In process samples(Reaction Monitoring),
- High pressure Liquid Chromatography (LC-2010A&LC-2010 AHT,Prominence) with LC Solutions software.(PDA & UV Detectors) ,
- Agilent 1200 series With EZ Chrome software(HPLC)
- Waters (2695 Separation Module & 2487 dual lambda Absorbance detector) with
Empower software.(HLC)
- Gas Chromatograph (GC-2014(HS), GC-2010(HS : AOC-5000), 14-B, 17-A) with GC solutions software.
- Gas Chromatograph –Head Space on GC-2010 with HT3 Head space
- UV-Visible Spectrophotometer (PerkinElmer)
- Fourier Transform Infrared Spectrometer (PerkinElmer)
- Specific optical Rotation (jasco Rudolph)
- Trained in Trouble Shooting of the instruments like HPLC & GC.
- MS-Office.
- Hard Working
- Self Motivated
- Sincere

[nit_pharma]

NITIN BANSAL
M. Pharm, Pharmaceutics,
E mail : nitinbansal.mpharm AT gmail.com
Objective
Seeking a position in leading organization where I can develop skills and gain experience by faithfully rendering services with utmost sincerity and dedication and where I can give best of myself so as to become an important part of organizational developments.
Area of Interest
- Drug Regulatory Affairs
- Formulation (R & D)
Qualifications
Sr. No. Degree/education College / university Year of passing Marks obtained %
1 M.Pharm (Pharmaceutics) IPS Academy, Indore/ RGPV Bhopal (MP) 2010 78.23%
2 B.Pharm St. Lawrence Pharmacy College, Delhi/ GGSIPU, Delhi 2008 78.91%
3 D.Pharm Board of Technical Education, Delhi 2005 64%
4 General Course on Intellectual Property Rights by World International Patent Organization Academy, Geneva.
Research Paper Published
- Research paper Published on “Formulation and Evaluation of Orally Disintegrating Tablets of Ondansetron Hydrochloride using Natural Super-Disintegrants and Comparison with Marketed Formulation” in “International Journal of PharmaTech Research”
Work Experience
- 18 months experience as “Quality Control Executive” in “GLOBUS PHARMACHEM” Ghaziabad (India).
- 45 days industrial training in Maiden Pharmaceuticals Ltd., Delhi.
- 3 months hospital training in St. Stephan’s Hospital, Delhi.
Research Work
- M.Pharm. Research Project :“Formulation and Evaluation of Mouth Dissolving Tablets of Ondansetron Hydrochloride using Natural Superdisintegrants”
- Experience in “Method development of simultaneous estimation of drug combination in pharmaceutical products using RP-HPLC and stability indicating assay using HPLC, UPLC and LC/MS”
Computer Literacy
- Working Knowledge of following Software’s :
Microsoft Office package (MS word, Excel, Power point)
- Scientific data retrieval from various Internet portals like Google scholar, Science Direct, Pubmed, etc.

[Guest]

CURRICULUM VITAE
ARUN ARYA
E-mail : arya_pharma19 AT yahoo.co.in



OBJECTIVE :

Intend to build a career with leading corporate of pharmaceutical environment with committed & dedicated people, which will help me to explore myself fully and realize my potential. Willing to work as a key player in challenging & creative environment.

EDUCATION :
- High School from CBSE Board, 1998.
- Intermediate from CBSE Board, 2000.
- B. Pharm from U.P. Technical University, Lucknow, 2006.
- M. Pharm (Pharmaceutics) from U.P. Technical University, Lucknow, 2008.

TRAINING EXPERIENCE :
- One month summer training during B.Pharm at ALKEM LABORATORIES PVT.LTD, Taloja (Mumbai), Maharastra.
- Industrial tour at CENTRAL INDIAN PHARMACOPOEIAL LIMITED (C.I.P.L.), Ghaziabad.
WORK EXPERINCE :

- Worked as lecturer in Department of Pharmacy, Mangalayatan University, Aligarh,
Uttar Pradesh (August 2009-April 2010).
- Currently working as Research Associate in Drug Regulatory Affairs at Ranbaxy Laboratories Limited, Gurgaon (April, 2010 – Till date)
- Regulatory fresh filings of Middle East Countries, Srilanka, Asia Pacific Countries (Thailand, Vietnam, China, Singapore) and Rest of Africa Countries (Algeria and Morocco).
- Re-registration, Variation filings of Middle East Countries and Srilanka.
- Responding the queries raised by the Agency’s of Middle East Countries and Srilanka.
- Maintaining the repositories and product history sheets of every transaction made for a particular product.
CURRENT SALARY :
- 3.2 Lac per annum.
COMPUTER AWARENESS :
- MS Office (MS WORD, EXCEL & POWERPOINT)
- Internet tools
EXTRA CURRICULARS :
- Participated in pharma quiz and stood second at college level.
- Regular Participant in various cultural activities in school and college level.
STRENGTHS :
- Confidence, love to face challenges, honest, hard working.
PROFESSIONAL AFFILIATION :
- Life Membership of Indian Pharmacy Graduate Association (IPGA)
LM- 3203.
DECLARATION :
I hereby declare that all the above information details furnished above are correct to best of my knowledge and belief.
DATE :
PLACE : (Arun Arya)