www.stardrugs.in Star Drugs & Research Labs Ltd Bangalore : Regulatory Affairs

[mskavi]

Star Drugs & Research Labs Bengaluru/Bangalore : Regulatory Affairs

Website: http://www.stardrugs.in

Designation: Regulatory Affairs
Experience: 3 - 5 Years
Location: Bangalore

Job Description:
experience in Regulatory Affairs in small volume parenterals in preparation of dossiers,documentation for obtaining licences,COPP & Free sale certificate,tender documents and sound knowledge of computers

Desired Candidate Profile:
Candidates having MSc/BPharm/MPharm having experience of three years and
More in Regulatory Affairs in small volume parenterals in preparation of dossiers,documentation for obtaining licences,COPP & Free sale certificate,tender documents and sound knowledge of computers.

Company Profile:
Star Drugs & Research labs Ltd., is one of the leading Pharmaceuticals Company in the country adhering strictly to international CGMP (Current WHO Good Manufacturing Practices) norms and manufacturing high quality injectables with unique compositions and High bio-availability at its state of the art Ultra-modern Plant in South India

Address:
Star Drugs & Research Labs
Plot No. 14
Sipcot II
Hosur,Tamilnadu,India 635109

Email Address: latha@stardrugs.in , viswanathan.cr@gmail.com

Keywords: Regulatory affairs in parenterals,preparation of dossiers / obtaining licences. etc

[Guest]

i am a graduate pharmacis. i have completed B-Pharma 2007 so iam interested to work in research so i am placing my reques

Thank you sir...

[prakash.regulatory]

I am Prakash. I am having 2 years and 10 months experience in Regulatory Affairs. During days I have learn more knowledge about regulatory and semi regulatory markets. I am looking a job for longer period. If any suitable jobs are available, please let me know.

[Guest]

dear sir, details of resume is below.

Rakesh Kothiya
M.Pharm. (Pharmacology)
Email: rakesh_pharma01 AT yahoo.co.in
Contact: 9974820084

CAREER OBJECTIVE
I am seeking a position with a pharmaceutical company that allows me to apply and enhance my skills of being a Master of pharmacy. I desire to gain quality experience that helps me to take full advantage of my degree in pharmacy. In addition, I am eager to contribute my creativity and hard work towards the success of company and to the growth of the fast developing field.

AREA OF INTEREST:

Regulatory Affairs , Clinical Research, Clinical Q.A.


EXPERIENCE:
Working as lead study coordinator in ICUBE clinical research on part time base.

Educational Trainings and Seminar Attended:
- Biogen Pharmaceuticals, Surat, Gujarat, India.
- Torrent Research Centre, Gandhinagar, Gujarat, India.
- National workshop on Clinical Research and Regulatory Affairs held at K.B.I.P.E.R. Gandhinagar.
- National seminar on Recent Advancement in Clinical Research sponsored by AICTE, held at K.B.I.P.E.R. Gandhinagar.
- Clinical Carnival at DDIT, Nadiad.


PHARMACY PROFILE:
Master of Pharmacy:

College/ Institute: K.B. Institute of Pharmaceutical Education and Research (KBIPER), Gandhinagar, Kadi Sarva Vishwavidyalaya, Gandhinagar, Gujarat, India.

Exam Year of passing Percentage Grade
Final semester Jun-2009 74% Distinction
Third Semester Jan-2009 68% First
Second Semester July-2008 67% First
First Semester Jan-2008 71% Distinction


Project Work:
Project done on Subacute Toxicity Study of amino acid infusion.

MAIN PROJECT WORK:
Phase III, Multicentric, Comparative Clinical Trial to Evaluate the Safety and Efficacy of Pregabalin SR formulation with IR formulation in Patients of Diabetic Neuropathic Pain.

Place of Work:
Torrent Research Centre, Bhat, Gandhinagar

Roles and Responsibilities as Project Trainee:

- Preparation of protocol, Informed consent forms, Case Report Forms for Bioavailability/Bioequivalence Study and Clinical Trials (Phase III, Phase IV).
- Monitoring of study sites in Multicentric Trial.
- Preparation of PSUR for DCGI Submission.
- Preparation of Expert reports for various products for Europe Submission and Preparation of Package Inserts/Prescribing information for various countries.
- Preparation of Final report of Phase III trial and BE studies for various Count


Bachelor of Pharmacy:
College/ Institute: T.V.M. College of Pharmacy (Rajiv Gandhi University), Karnataka, India.

Exam Year of passing Percentage Grade
Final Year Feb-2007 73% Distinction

Third Year Feb-2006 76% Distinction

Second Year Jan-2005 72% First
First Year Feb-2004 71% First


Professional Achievements:

- Stood 7th University Rank in Pharmaceutical Jurisprudence.
- Qualified GATE-2007, Kanpur with All India 548th Rank.


Extra Curricular Activity:

- Participated in regional level Kabaddi and inter college Cricket tournament.
- Participated in college Cultural Festival.
- Performed duty as Class Representative.

Key Strengths:

- Hard working and agree to perform duty at any place of India.
- Personal drive and commitment to achieve results.
- Sound technical aptitude with an eye for detail and commitment to producing quality work. Organized, hard working and fast learner.
- Excellent problem-solving skills enabling analysis. Reliable, punctual, trustworthy and conscientious.


Pre-Pharmacy Studies:

Course S.S.C. H.S.C.
Year of passing March-2000 March-2002
Percentage 85% 63%
Grade Distinction First


Personal Details:

Date of Birth : 1thJuly, 1985
Marital Status : Single
Present Address : A/2, Sahjanand Appartment,
Plot no. - 329, Sector-12,
Opp. Police Choki,
Gandhinagar-382023
Language Known : English, Gujarati, Hindi
Mobile No. : +919974820084
E-mail Id. : rakesh_pharma01 AT yahoo.co.in

[mahendra7kuril]

DEAR SIR
I HAVE DONE MY M.PHARMA IN DRA FROM JAIPUR NATIONAL UNIVERSITY JAIPUR , NOW I WANT JOB IF U HAVE ANY PLEASE REPLY
REGARDS
MAHENDRA

[ssarun07@gmail.com]

hello sir /mam....iam fresher with b.pharmacy i want a job in your company ..i send my resume now if any vacant is there means please call for me...........

[Rahul uchit]

Name :Rahul shankarrao uchit
Education[]:mpharm