MRUDULA CHAVAN

***, **** ******, ***.**, Brooklyn, NY 11220

952-***-**** • acuo84@r.postjobfree.com

OBJECTIVE: To seek a position which will enhance my working skills and put the knowledge gained through academic learning to its optimum use to benefit the organization

SUMMARY OF QUALIFICATIONS:

Compiled and submitted Investigational New Drug Application for a fictional drug NOFIT, Phenymazeine, particularly the CMC section ( Module 3) as course project work

Developed Corrective and Preventive Action Plan(CAPA) for a pharmaceutical manufacturing company in response to a warning letter received from USFDA as course project work

Knowledge about submitting regulatory documents like IND, NDA & ANDA in CTD format as per FDA guidelines; working knowledge of e-CTD software system, eCTDXPress

Comprehensive understanding of USFDA approval process for marketing a drug and able to comprehend and interpret FDA and ICH guidelines

Understanding of the drug approval process and regulatory strategies in the European Union, Japan and Canada

Knowledge of new drug development and clinical trials process, medical devices, GMP, GCP, GLP, orphan drug regulations and regulatory strategies of developing CAPA

Ability to work in a team as well as independently to meet deadlines with excellent presentation and communication skills

EDUCATION:

Long Island University Brooklyn Campus, Brooklyn, NY Current GPA:3.96/4.0

Masters of Science in Drug Regulatory Affairs; Expected: May 2016

Sterling Institute of Pharmacy, Navi Mumbai, India

Bachelors of Pharmacy June 2013

HONORS & AWARDS:

The Rho Chi Society- Beta Theta Chapter February 2016

CERTIFICATION:

Maharashtra State Pharmacy Council, Registered Pharmacist, July 2013

EXPERIENCE:

Graduate Assistant May 2015- Present

Long Island University, Brooklyn Campus, New York

Assisting faculty and administrators of the Division of Pharmacy Practice in delivering College's curriculum

Assisting faculty with course-related special projects

Assisting faculty in teaching of recitations for PharmD students

Helping students in locating articles by exhaustively searching different resources, books, troubleshooting computer/printer issues

Retail Pharmacist November 2013- June 2014

Mukesh Medical & General Store, Thane, Maharashtra, India

Served as full time Retail Pharmacist and consultant

Counseled patients regarding administration of drugs according to prescription

Maintained patient records using Pharmacy software system

Managed drug inventory by processing orders and verifying deliveries

Placement Student Coordinator June 2012- May 2013

Sterling Institute of Pharmacy, Navi Mumbai, India

Contacted various organizations to schedule campus interviews with different pharmaceutical companies

Attended seminars and participated in innovative campaigns conducted by Indian Pharmaceutical Association

Summer Intern May2011- June 2011

Maneesh Exports (EOU), Navi Mumbai, INDIA

Completed industrial training in Manufacturing, Quality Control, Quality Assurance, Packing and Labelling Department

Documented product details in Store Department software system

PROFESSIONAL AFFILIATIONS:

Maharashtra State Pharmacist Association, Member July 2013- Present

COMPUTER SKILLS:

Proficient in Microsoft Word, Power Point and basic knowledge of Excel, Outlook and Adobe

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