Ms. PREXA NITIN SHAH

Date of Birth: 05/12/1992

Address: 2514 Crestline Drive, Lansdale, PA- 19446, USA

Phone: (848)234-0429

Email Address: shahprexan@yahoo.com/ shah.prex@husky.neu.edu

LinkedIn: https://www.linkedin.com/in/prexa-shah-bpharm-ms-reg-19887b58

Objective:

To utilize my academic and industrial experience and sincerely work as a full time/part time associate in the field of Regulatory Affairs/ Quality Assurance.

Education:

Master of Science in Regulatory affairs for Drugs, Biologics and Medical Devices- Northeastern University, Boston, MA -September 2015 - April 2017 GPA: 3.8/4.0 Courses taken till date-

• Introduction to Drug and Medical Device Regulations• New Drug Development: A Regulatory Overview• Advanced Writing on International Biomedical Topics• Global Biotechnology Product Registration: E.U., U.S. Product Regulation• Biologics Development: A Regulatory Overview• Medical Device Development: A Regulatory Overview• Introduction to Canadian, Asian and Latin American Regulatory Affairs • Regulatory Writing: New drug applications• Strategic planning and project management for regulatory affairs• Canadian and Australian Medical device regulations

Bachelor in Pharmacy-Gujarat Technological University, Ahmedabad, Gujarat, India.Grade: 7.3/10.0 -July 2014

During my bachelor’s program I have garnered in depth knowledge in various areas including Pharmaceutical analysis, Pharmacology, Clinical pharmacy, Medicinal chemistry, Pharmaceutics and Dosage form design.

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Experience:

Invatech Pharma Solutions LLC, New Jersey, USA October 3, 2016-December 3, 2016Designation- Quality Technician

Job Description/Job Responsibilities- To perform routine product release testing and product stability testing under cGMP

guidelines, and provide routine testing support for lab release, R&D, batch size increases, operations equipment qualification and process validation.

To maintain laboratory documentation with details of test procedures, raw data, and final results in accordance with regulatory guidelines.

To prepare and review Method Validation Protocols, Method Validation Reports, Specifications and Method of analysis.

Intas Pharmaceuticals Limited, Ahmedabad, India -November 2014 -August 2015Designation- Quality Assurance Associate- QMS (Quality Management System)

Job Description/Job Responsibilities-.• Monitoring and logging of Change Requests and Corrective and Preventive actions

(CAPA).• Handling with Deviations.• Issuance, Control and Review of documents such as Batch Manufacturing/Packaging

Records and SOPs.• Maintaining control and ensuring GDP compliance for all documents and registers.• Coordinating with client/ MA holder/ PL holder for change request and deviation

approval.

Industrial Training:

During my final year at college, I went through several weeks of intensive industrial training at Nirma Ltd. (HealthCare Division) which is a multinational organization manufacturing antibiotics and water for injection, Medical devices and IV fluids including Critical care medicines. I worked in their production, testing and quality control and quality assurance departments. Additionally, I even focused on documentation and regulatory affairs.

Academic projects and seminars:

Northeastern University-

• Created an Informed Consent template and Clinical Protocol for Phase-1 clinical trial, in accordance with the federal regulations.

• Made a Standard Operating Procedure (SOP) as per GMP and GDP guidelines.

• Prepared cover letter for supplement to a BLA.

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• Analyzed a warning letter from FDA, and presented possible solutions and recommendation, in accordance with CGMP.

• Prepared and presented a PowerPoint presentation focusing on the approval process of an anticoagulant drug- “Praxbind”.

• Composed a research paper on “Reasons explaining higher rates of depression in United States in comparison to Italy”.

Gujarat Technological University-

• Prepared and presented poster on “Iontophoretic Drug Delivery System”, researching on latest and alternative methods for drug design and delivery, in Intercollege Poster Presentation Competition.

• Prepared a PowerPoint presentation on “Sample Handling Techniques in Infrared Spectroscopy” covering methods of preparation of solid, liquid and gaseous samples.

• Attended and actively participated in following educational seminars –

• National seminar on “Nutraceuticals and Dietary Supplements – Global Regulatory Challenges and Opportunities”.

• National conference on “Global Scenario of Herbal Drugs Today and Tomorrow”.

• Seminar on “Scope of Pharmacists in India and Abroad”.

These have not only given me knowledge about latest developments in the field, but also made me aware of requirements in terms of research and developmental endeavors in order to realize the latent potential within these.

Skills and Hobbies:

• Equipped with in-depth knowledge about requirements essential for FDA submissions (IND, NDA, ANDA and BLA).

• Appropriate knowledge of drug development and approval process in USA, European Union, Japan and other ROW markets.

• Good understanding of medical device regulations for IDE, 510k and PMA.• Profound knowledge and training with GLP, GCP, GMP and ICH guidelines.• Fundamental understanding about basics like Regulatory documentation, 21 CFR

regulations, eCTD submissions, Quality system regulations, Orphan drugs, Combination products and Warning letters.

• Efficiency in reviewing documents like SOPs, change request forms and batch manufacturing/packaging records in accordance with GDP.

• Good command and competence over basic practical skills like formulations, compound synthesis, clinical pharmacology and analytical chemistry.

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• Excellent verbal, communication, analytical and writing skills, strong organizational and time management skills, willingness to learn, work as a team, fluent English speaker and hard worker.

• Responsible, enthusiastic, creative, disciplined, punctual, spontaneous learner, agile problem solver, confident, self-motivated, proactive and extrovert.

• Well acquainted with the usage of SAP and proficient in using MS Office.• Interests include networking, playing badminton and chess, travelling and watching

movies.

Work/Employment status/eligibility: F1 OPT. Eligible and willing to work for any employer in United States. No sponsorship for H1b is required.

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