Regulatory Affairs Associate

JIMMY D. BHATT

*** ******* ******, ****** ****, NJ 07306 • 732-***-**** • ***********@*****.***

OBJECTIVE

A position where my knowledge of pharmaceutical science and managerial skills can be utilized

PHARMACEUTICAL EXPERIENCE

PHARMACIST, Fedora Solutions Company, Gujarat, India June-Dec 2008

• Communicated with doctor offices and patients in the USA to validate prescriptions for oncology, based on PDR

• Coordinated in credentialing process with US-based health insurance provider such as Blue Cross Blue Shield, Cigna, Medicare, Medicaid, United Healthcare and Aetna in HIPAA compliance

PHARMACY INTERN, Torrent Pharmaceutical Ltd., Gujarat, India Summer 2007

• Participated in manufacturing process of tablets and capsule starting from mixing of ingredients to finished products as per US Pharmacopoeial standards

• Validated and operated instruments such as HPLC, UV- Visible Spectrometer etc in compliance to cGMP and GLP requirement and collected data to ensure safety and stability of product

• Knowledgeable for recruiting and evaluating potential investigator, inform consents (ICF) and ICH- GCP guidelines

• Knowledgeable of collecting data required for chemistry, manufacturing and control(CMC) as a part of ANDA submissions and handling of various Drug Master Files(DMF)

EMPLOYMENT HISTORY

GRADUATE ASSISTANT, Computing Services, Fairleigh Dickinson University, NJ May 2010- May 2011

• Managed and supervised team of 20-25 lab assistants across campus

• Scheduled and prioritized reservation process to achieve optimal use of available resources

• Worked closely with lab manager and team of lab assistants to ensure best customer service

MARKETING/ SALES INTERN, Perfume Galaxy, Paramus, NJ March 2010-March 2011

• Marketed fragrances and cosmetics products to customers

• Assisted in training new sales associate and managed optimum level of inventory

• Maintained relationship with suppliers and customers to boost sales

EDUCATION

MBA - Pharmaceutical Management, Fairleigh Dickinson University, NJ May 2011 3.77 GPA

• Relevant Coursework: Financial Analysis, Pharmaceutical Supply Chain and Regulatory Affairs (FDA,CAPA & ISO guidelines), Pharmaceutical Marketing, Production & Operation Management, Statistical Analysis, Strategic Management, Pharmaceutical Industry & Government Regulations , Pharmaceutical Research & Clinical Trials

Bachelor of Pharmacy, Gujarat University, India May 2008 3.8 GPA

• Relevant Coursework: Industrial Pharmacy, Organic Chemistry, Medicinal Chemistry, Clinical pharmacy, Dosage Form Design, Quality control & Quality Assurance, Pharmaceutical Engineering, Pharmacology

PROJECT

Paper: Regulation of Medical Devices Fall 2010

• Explained evolution of regulations in field of medical devices including 510(K) submissions and PMA

• Described classification(Class I,II,III) of Medical devices based on safety profile

Project: Marketing Plan for a Glucose Measuring Instrument Fall 2010

• Conducted market analysis and competitors’ analysis for a newly developed product

• Created market map and located target audience based on market deciles

• Projected growth potential of targeted market and forecasted demand and sales

HONORS

Recognized by International Honor Society Beta Gamma Sigma for Academic Excellence in MBA

Colonel Fairleigh Dickinson Scholarship for five consecutive semesters

COMPUTER

Proficient with MS software suite, ABI/Inform, Pub Med and Production & Operation Management (POM) for Windows

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