Customer Service Quality Assurance

AMIT SOLANKI

**** ******* **** *****

Richmond, TX 77407

Mobile: 551-***-****

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

OBJECTIVE:

To obtain a challenging, growth oriented position within regulatory affairs that adds value to an organization

through continuous process improvements, client satisfaction, and company commitment

EDUCATION:

09/2005 – 05/2009 Masters, Drug Regulatory Affairs, Long Island University (LIU)

05/2002 Bachelor of Science New Jersey City University (NJCU)

PROFESSIONAL STRENGTHS:

• Over five years of experience in the pharmaceutical industry

• Dedicated, articulate and enthusiastic with strong analytical and organizational abilities

• Effective communication and interpersonal skills with the ability to interact effectively in cross-

functional teams and with external organizations

• Ability to work independently or as an integral part of a team to accomplish goals

• Experienced in prioritizing and completing numerous concurrent responsibilities in a detail-

oriented manner while meeting deadlines and organizational goals

• Professional attitude, strong work ethics and pride in personal performance

EMPLOYMENT HISTORY:

03/2009 – 07/2009 Forest Research Institute/ICON

Clinical Trial Associate, Forest Research Institute

• Participate in different aspects of clinical development and study management under the

direction of the Director, and Associate Director, which includes providing scientific, and

logistical support for planned and ongoing trials

• Contribute to process improvement efforts by developing SOPs and Work Instructions within

the Clinical Operations to enhance productivity and correct inefficient business practices

• Collect and review study related regulatory and financial documents

• Attend clinical team meetings and assist with the meeting agenda and minutes

• Interact with CRO’s and vendors plus track and process payments for sites and vendors

• Communicate and support field monitors, IRBs and outside vendors as to study issues and

updates

• Support and correspond with investigative sites as necessary, including ordering study drug and

other trial related supplies

• Assist in the preparation of project-specific training programs and training materials for internal

and external groups

• Maintain a working knowledge of GCP/ICH guidelines plus FDA regulations

04/2006 – 03/2009 ImClone LLC

Sr. Regulatory Affairs Associate, ImClone Systems Corporation

• Review regulatory packages (1572, IRB Approval, Informed Consent Forms, and Clinical

Protocols)

• Responsible for timely preparation, compilation and publishing of electronic regulatory

submissions as well as DDMAC submissions (pre-clearance and 2253)

• Support submission related project activities (tracking submissions, processing queries,

recording meeting minutes)

• Perform QA reviews of submissions and provide mandatory corrections to ensure compliance

with FDA and ICH guidelines

• Assist in the management of deliverables from project matrix teams, third party vendors and/or

development partners to ensure effective project communication and coordination

• Develop SOPs and Work Instructions within the Regulatory Operations to enhance productivity

and correct inefficient business practices

• Utilize various systems such as FirstDocs along with eCTDXPress

• Maintain a working knowledge of laws and regulations, policies and standard procedures

relating to drug development and regulatory operations

02/2004 – 04/2006 Pfizer Inc. /Adecco Technical

Regulatory Affairs Associate, Pfizer Inc.

• Responsible for maintaining, organizing regulatory submission files and associated

departmental documents in accordance with legal requirements, as well as corporate standards

for records retention

• Accountable for the preparation, compilation and publishing of Pfizer Consumer Healthcare

paper submissions to the Food and Drug Administration.

• Effectively interacted with all internal and external personnel to handle requests for information

pertaining to various products

• Research and compile data in compliance with FDA standards in relation to IND, NDA, 510K,

ANDA and clinical trials

• Evaluate potential impact and communicate current government regulations and guidance to

project teams

• Interface with Consumer Healthcare departments to gather and consolidate mandatory data in

order to meet FDA timeframes

• Supervise and train temporary employees in the technical skills that are mandatory to maximize

efficiency, accuracy and productivity

11/2002 – 12/2003 Pfizer Inc. /United Staffing

Medical Data Coordinator, Pfizer Inc.

• Maintained documents for assigned studies at the prescription drug product division

• Aided Sr. Managers with various projects in the department related to investigators, sub-

investigators and IRB approvals

• Successfully handled customer service requests for retrieving IND, NDA, PSUR, DMF

regulatory information and clinical trials

• Generated and tracked data for active and transferred documents

06/1999 – 04/2002 Lab Technicians, Kelly Scientific Resources

• Executed temporary assignments at scientific, client based pharmaceutical, biotech, chemical

and medical sites

• Provided quality control checks and quality assurance testing on pharmaceutical products and

ensured compliance with FDA regulations and guidelines

• Maintained equipment required for the development and manufacturing of solid dosage forms in

compliance with GLP, cGMP and safety requirements

• Responsible for conducting laboratory testing of syringes, food product stability and assisted

with plant maintenance

TECHNICAL SKILLS:

Technologies: ISI ToolBox, ISI eCTDXPress and Adobe Acrobat 5.0 & 6.0

DMS: Documentum and FirstDoc, eRoom

Microsoft Office: Microsoft Office and Visio

Other: RADARS (Submission tracking system), PISCES and GIFTS

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