Regulatory Affairs, Clinical Reasearch Data Analyst

RESUME

Alok K. Naik

Email:*.*.******@*****.***

Phone: 201-***-****

Summary

Enthusiastic professional with strong interest in varied areas of Regulatory Affairs for drugs and medical devices. Quick learner with ability to work individually and as a coordinator/team player. Motivated to make career as a Drug Regulatory Affairs Professional available to work full time from August 1st, 2011

Education

Masters of Science in Drug Regulatory Affairs (Sep 08 – May 11)

Long Island University, Brooklyn, NY

Coursework: Mechanics of preparing IND and NDA and ANDA , Regulatory Compliance, Pharmaceutical labeling advertising and promotion, Regulations of OTC drugs, Medical Devices and Cosmetics, Food and Drug Law

Bachelor of Science (Jul 03 - May 07)

Bharati Vidyapeeth University, Pune, India

Professional Experience

Cognizant Technology Solution (Mumbai, India) (Oct 07- May 08)

Position :Data Analyst, Pharmacovigillence

(Novartis OTC , US and Canada )

Responsibilities:

•Capturing and Reporting Adverse Event

•Assisting Novartis OTC consumers

Astral Pharmaceutical Industries,Vadodara, India (May 06 – Jul 06)

Position: Trainee

Knowledge Gained:

•Exposed to planning activities related to ANDA projects for various Drug Products of Sterile Antibiotic powder injectables of Cephalosporin Range and Semi Synthetic Penicillin range

•Exposed to manufacturing and Quality Management Systems of the facility

Zydus Cadila, Ahmedabad, India (May 05 – Jul 05)

•Quality Control checks on Raw Materials

•Quality control of Tablets and Powders

Projects,Presentations and other info

•Actively participated in preparing IND as a class project during graduation.

•Worked as a Tutor for undergraduate students at Academic Reinforcement Centre, Long Island University from Jan 2009 to May 2011

Computer Skills

•Friendly with Microsoft Word, Excel, Power point and SPSS, Can adopt quickly with the e CTD format.

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