MEET PATEL

*** **, **** ****, ***** Meadows, NY-*1366

339-***-****, acvhy0@r.postjobfree.com

OBJECTIVE

To become a successful regulatory affairs professional, so that I can utilize my pharmaceutical industry knowledge in managing the product life cycle of existing products and providing regulatory advice on upcoming products to market.

RELEVANT EXPERIENCE

Milichem Laboratories, Mumbai, India July 2013- April 2014

Sales Representative

Act as a liaison between the company and the government body.

Offering feedback on best strategies to achieve legal and regulatory compliance or how policy changes can improve conformity.

Updating the company with new legal landscape in the field of medicines that changes due to ever increasing science and technology.

Liberal Pharmaceuticals, Mumbai, India April 2012- May 2012

Internship, QA/QC Department

Observing and learning about the various sections of the industry such as tablet manufacturing and packaging, liquid manufacturing and packaging and capsule manufacturing and packaging.

Ensuring that proper good manufacturing practices is followed.

Ensuring that the drug product components, containers and closures flow in a systematic manner in the company and stored separately in the respective area to prevent contamination.

Recording and analyzing the observations of QA/QC test of the given tablet samples such as dimensions, weight variations, hardness, dissolution, disintegration and friability.

Sampling and sampling technique, and ensuring proper SOP is followed for everything.

Storage of in-process materials, rejected batch, finished products separately to prevent contamination.

EDUCATION

St. John's University, New York Sept 2014- May 2016

Masters of Science in Pharmacy Administration in Drug Regulatory Affairs/Quality Assurance

Courses- Biostatistics, Foundation of Regulatory Affairs, Regulatory Submissions and Drug Regulatory Process, Process Validation, Scientific Inquiry: Regulatory and Ethical Challenges, Foundation of GxP, Advanced Food and Drug Law, Basic Concepts of Drug Development Process, International Drug Regulatory Affairs.

Projects-

Term paper on cleaning validation of sandwich toaster.

- We developed SOP on cleaning validation of sandwich toaster.

Presentation on consent for organ donation- balancing conflicting ethical obligations.

Conducted a comparative study of the U.S. regulations pertaining to the Medical Device with that of the Germany.

- Classification of medical device, laws and amendments associated with it, how to market it, role of ethics, recalls, labeling requirements, post marketing surveillance, and IMDRF were covered in the above mentioned study.

Responsible for preparing and submitting IND of the product as per eCTD.

- Successfully created CTD for the drug 'Movantik' as part of the class project and personally responsible for creating Module 1 for the same.

FDA warning letter on violation of cGMP.

- We analyzed FDA warning letter on violation of cGMP at Cadila Healthcare Ltd and factors that triggers to such violations.

FDA warning letter on violation of GCP.

- We analyzed FDA warning letter on violation of GCP at Pikeville Medical Center Inc and factors that triggers to such violations.

Mumbai University, India 2009-2013

Bachelor of Pharmacy

Courses- Pharmaceutics, Pharmacology, Biopharmaceutics, Forensic Pharmacy, Cosmeticology, Pharmaceutical Analysis, Medicinal Chemistry, Organic Chemistry

OTHER EXPERIENCE

Graduate Assistant, College of Pharmacy

St. John's University, New York Jan 2016- May 2016

Assisting teaching fellow in conducting Physical Pharmacy lab.

Evaluating and grading their pre and post lab assignments and also commenting on their final product.

Clarifying lab-related doubts/questions.

Teaching Adjunct, Biology Department

St. John's University, New York Aug 2015- Dec 2015

Laboratory instructor for Biology for undergraduate students.

Planning, developing and managing syllabus material,

Organizing field trip to American Museum of Natural History and then conducting quiz based on what they observed, thus helping them to understand the evolution of animals.

Input midterm and final grades into the Blackboard system of university.

Excel Pharmacy, Brooklyn, New York Feb 2015- Nov 2015

Volunteer

Inventory control: Ensuring that the products are there on the shelf in right quantity.

Checking invoice whether product ordered is shipped with right quantity.

Answering and responding to customers inquiry, assisting them with proper OTC product selection.

Solving computer related problems thus acting as a technician.

Monthly checking products for expiry date and storing them separately in order to prevent contamination.

EXTRA CURRICULAR ACTIVITIES

Captained college cricket team in Dec 2012.

Presented poster at IPA SF MSB conference.

Worked in the college cultural committee in the year 2011-2012.

Volunteered in health campaigns organized by MDACS (Mumbai Districts AIDS Control Society).

- Blood donation, Anti-HIV, Anti-Diabetes, Anti-Tobacco.

SKILLS

Computer skills: Microsoft Word, Excel, Power Point.

Language: English, Hindi, Gujarati, Marathi.

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