www.Alpha-Pharma.com Healthcare Mumbai : Regulatory Executive

[Rajkumargautam]

Alpha-Pharma Healthcare Mumbai : Regulatory Executive

Designation: Regulatory Executive
Experience: 5 - 10 Years
Location: Mumbai

Job Description:
Alpha-Pharma is currently employing a qualified pharmacist with regulatory background for participation in its operation based out of Mumbai.

Desired Candidate Profile:
We would be interested in you joining our team if you :
• Are a B.Pharm or M.Pharm graduate.
• Have solid experience in DMF, CPP, dossier development and product registration in India as well as abroad.
• Are a fast learner and are able to familiarize yourself with guidelines, requirements and regulations in a fast moving environment.
• Are experienced in WHO regulations and are able to pin-point defaults and flaws in documentation for drug master, CPP and dossier files.
• Are absolutely fluent in both verbal and written English and easily able to understand foreign accents.
• Are a team player but yet able to work on your own.

Job tasks :
• DMF, CPP & Dossier development for registration in Asia, Latin and South America.
• DCGI & Local FDA interaction to obtain product registration & import/export permission.
• Assisting our marketing team with their requirements for documentation.
We expect that you are creative, reliable and open to new concepts. Our office is based in the western suburbs from where you will be working in close relation with our Managing Director and Marketing Manager for launch of new products and production facilities.

Company Profile:
Alpha-Pharma is specialized in generic drugs under which we mainly focus on androgens and anti-androgens. Our primary focus is exports while we are currently penetrating the Indian domestic marked.

Address:
Alpha-Pharma Healthcare
#A-317, Sagar Tech Plaza
Sakinaka Junction, Andheri (E)
Mumbai,maharashtra,INDIA 400072

Email Address: vacancy@alpha-pharma.com
Website: http://www.Alpha-Pharma.com

Keywords: Regulatory, Pharmaceuticals, Pharmacist, Pharma

[Saket]

Saket Gupta
C - 284, 2nd Floor
Alpha – 1, Greater Noida
G.B.Nagar, (U.P.)- 201308
Mobile: +919911053850
E-mail: gupta_saket86@yahoo.co.in



SAKET GUPTA

Objective

I look forward to reach an eminence by exploring my knowledge and skills in clinical research, to contribute efficiently towards the organization that offers security and professional growth to my career.

Working Experience

· Worked as a ‘Business Executive’ in “RANBAXY LABORATRIES LTD.” for 7 months from Dec 2007 to Jun 2008.

· Worked as a ‘Field Sales Officer’ in “INTAS PHARMACEUTICAL LTD.” for 5 months from July 2007 to Dec 2008.

Personnel skills
· Clinical research phases.
· Knowledge of ICH-GCP, US-FDA and Schedule Y.
· New drug application (NDA) & Investigational new drug (IND)
· Good understanding of Pharmacovigilance.
· Data Capture & Data Validation,
· Completing and Preparing Monitoring Reports / I.B. / SOP Writings/ Drug Accountability Form/ Periodic Visit Checklist/ Inform Consent Form/ Case Report Form/ Protocol Writing/ Source Data Verification.
· Knowledge of Outsourcing in Clinical Research, Ethics Committee, Study Feasibility & Site Selection, Site Initiation Visit, Patient Recruitment & Retention, Business Development in Clinical Research & Investigator Meeting.

Professional Qualification

· Pursuing Post Graduate Diploma in Clinical Research fromHindustan Institute of Medical Sciences & Research, Greater Noida.
· Post Graduate Diploma in Drug Regulatory Affairs from Jamia Hamdard University, New Delhi, with 68% in 2008.
· B.Pharmafrom Ram-Eesh Institute, Greater Noida affiliated to Uttar Pradesh Technical University, Lucknow, with 72% in 2007.

Areas of Interest;-
Pharmacovigilance
CRA
Medical Writing

Educational Qualification

[LIST][*]Intermediate from U.P.Board in 2002.[*]High School from U.P.Board in 2000.[/LIST]

Computer Cognizance

· Knowledge of MS Office
· Knowledge of Operating Systems: MS-DOS, WIN 98/2000/XP.
· Language C.

Training Experience

(In 3rd year)
[LIST][*]ASTRON PHARMACEUTICALS PVT.LTD. NEW DELHI [/LIST]
Seminar Delivered
§ Tablet coating

Industrial visit to following company
§ TORRENT PHARMACEUTICALS
§ PANACEA BIOTECH. LTD.
§ MORPEN PHARMACEUTICALS

Personal Profile

Date of Birth
20th May 1986
Sex
Male
Passport No.
G 2685127
Father’s Name
Dr. Rajkumar Gupta
Nationality
Indian
Languages
English & Hindi
Permanent Address
Bara Bazar, Marehra Dist. ETAH -207401

[Guest]

RESUME

Amantullah Hashmat Hussain Shaikh
amanat_hh AT yahoo.com
amanat98 AT gmail.com

Objective :
Seeking a reputable position as “Hospital Pharmacist” to apply my skills and knowledge in the field of medicines in a reputed organization.
Total Professional Experience :

- Working as a “Pharmacist” in “Rahmania Hospital” Mumbra, Mumbai.
- Worked as a Registered Pharmacist for Ruby Chemist, Malad (w) Mumbai. From. December 2001 to May 2003.
- Worked as a Pharmacy In Charge for Star Pharma.
- Worked as a Pharmacist in Al Habtoor Leighton Group (Main Pharmacy Store), Dubai. From August 2008 to December 2010.
Summary of Skills :
- More than 9 years of pharmacy experience.
- Ability to handle all works related to Hospital Pharmacist.
- Excellent customer service and interpersonal skills.
- Capable to work independently and as a part of a dynamic team.
- Attention to detail with good interpersonal skills.
- Flexible, organized and team oriented.
- Fluent in English.
- Strong knowledge of mathematical and science.
- Good assessment and problem solving skills.
- Positive attitude towards patients in critical situation
Technical Skills :
- Familiar to work in PC environments.
- Highly skilled in using Microsoft Word, Microsoft Front Page and Auto Cad
Educational Qualification :
- Passed Diploma in Pharmacy (two years course) from Maharashtra Board of Technical Educational in 2001.
- Registration No. 59152 (Maharashtra State Pharmacy Council). India

Computer Certification :
Diploma in Information Technology from C-DAC in year
2000 with B+ grade
Duration : Three Months
Course Content : MS Word, Exel, Power Point, Internet Surfing, and Hardware
Maintenance