International Regulatory Affairs Professional

Lipi Desai, B.Pharm, M.Pharm, PGDRA

Scottsdale, AZ

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

Tel: +1-480-***-****

Regulatory Affairs Specialist with almost two years of work experience in pharmaceutical drug regulatory affairs looking to provide innovative and quality service in a dynamic team of Regulatory affairs professionals.

Work experience

SCIENTIST II, Department of International Regulatory Affairs Torrent Pharmaceuticals Ltd. Ahmedabad, India.

October-2014 to July-2015

● Prepared regulatory filings for submission of dossiers of three previously approved drug products for clients in India and Europe to the EMEA, MHRA and other national authorities in Europe, which resulted in their approval.

● Assisted the project manager in responding to the queries of regulatory agencies post submission.

● Prepared post approval submissions (variations and renewals) for drug products as per the regulatory guidelines.

JR. EXECUTIVE, Department of International Regulatory Affairs. Claris Lifesciences Ltd. Ahmedabad, India

July-2013 to April-2014

● Successfully prepared dossiers for countries in CIS & Latin America as per the current guidelines.

● Ensured timely submission of other requirements (if any) after dossier dispatch.

● Prepared response to queries received post-submission.

● Ensured that the product registration & renewal dossiers are compiled within deadlines.

● Verified the technology transfer documents.

● Communicated with respective country manager with day-to-day updates regarding the projects.

INDUSTRIAL TRAINEE, Analytical Department

Astron Research Ltd., Ahmedabad, India

July 2012 to December 2012

Utilized techniques such as HPLC, Ion chromatography, UV-Visible Spectrophotometry, Titrimetric, Stability studies, impurity profiling, for pharmaceutical analysis of drug products in the developmental pipeline. Professional Skills

● Working knowledge of regulatory guidelines for EMA, CIS and Latin America, and sound knowledge of the FDA guidelines.

● Keeping close track to regulatory changes guidelines and interpreting their implications on the drug development and authorization process

● Critical review of regulatory documentation with regards to quality, safety and efficacy in order to prepare a document congruent with regulatory guidelines and other legal requirements

● Communicate effectively and to function as a representative to both internal and external parties

● Coordinate application procedures for approval of medicinal products by developing realistic action plans and prioritizing work activities.

● Ability to synthesize complex information and convert it in a comprehensible manner

● Competent with Microsoft Word, Excel, PowerPoint, Outlook Education

POST GRADUATE DIPLOMA IN DRUG REGULATORY AFFAIRS (PGDRA), 2013 Gujarat University, India.

Grade: 82%

Modules covered:

Pharma Regulation practices and procedure

ICH guidelines for drug substances and products

Overview of regulatory guidelines of major markets such as USA, EU, ANVISA and India.

Basic concepts of clinical trials and regulatory compliance

Bioavailability and bioequivalence for USFDA compliance

Understanding the structure of mandatory documents required for compiling a dossier (Master Formula Record, Master Formula Card, Material Safety Data Sheet and Drug Master File)

Basic concepts of Intellectual property rights (Indian Laws)

Quality Assurance and Regulation

MASTER OF PHARMACY, 2013

Ganpat University, India.

Grade: 69%

Major: Quality Assurance

All India G-PAT (Graduate Pharmacy Aptitude Test) – 2011, Grade 96% Research project: “Development and Validation of Analytical methods for Estimation of Bosentan Monohydrate in Pharmaceutical Dosage form.” Findings: As a part of the dissertation work, three different analytical methods (Two methods using UV-Visible spectrophotometer and one of High Performance Liquid Chromatography) were developed for assaying the drug - Bosentan monohydrate in tablet dosage form. All the three methods were validated and finally comparison was done by applying some statistical treatments.

BACHELOR OF PHARMACY, 2011

KSV University, India.

Grade: 64%

Research project: “Formulation, Evaluation & Marketing Strategy of skin care cosmetic

(Moisturizer)”

Findings: The work consisted of the different stages like; market survey (to identify some of the popular cosmetic brands), formulation of cosmetic product (Moisturizer), evaluation of the product (Organoleptic, IPQC, QC, Stability) and marketing strategy for the developed product (brand name, logo, tag line, labelling, packaging, market segments, customer targeting and promotional activities).

Other Accomplishments

● Member of organizing committee for a Tech fest “Apocalypse” (August 2010) at K. B. Institute of Pharmaceutical Education and Research, India.

● Team leader in a competition - IPSA (Industrial Problem Solving Abilities). “Pharma Festival” (March 2012): A Pharma event at L.M. College of Pharmacy, Ahmedabad.

● Delegate at National Workshop (April 2012): “Advances in Chromatography” at S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, India.

● Delegate at National Seminar (July 2012): “Recent Trends in Pharmaceutical Analysis & Regulatory requirements” at S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, India.

Publications (under maiden name)

1. Paresh U Patel, Lipi G Baxi “Development and Validation of Derivative Spectrophotometry and RP - HPLC methods for Estimation of Bosentan Monohydrate in Pharmaceutical Dosage form”, Inventi Rapid: Pharm Analysis

& Quality Assurance; 2013(2): 1-9, 2013.

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