Microsoft Office Clinical Research

KARISHMA R. SHAH

****.*@*****.***.*** 201-***-**** 821 Pavonia Avenue, Jersey City, USA

EDUCATION

Masters in Regulatory Affairs (June 2017-Expected)

Northeastern University, Boston, USA

Courses: Drug and Medical Device Regulatory Affairs, Biologics Development: Regulatory Overview,

Project Management in Early Drug Discovery, Human Experimentation.

Masters in Clinical Pharmacy (June 2013)

KB Institute of Pharmaceutical Research, Gandhinagar, India Courses: Advanced Pharmacology and toxicology, advanced pharmacokinetics, Clinical Research,

Hospital Pharmacy Management, Intellectual Property rights.

Bachelors of Pharmacy (May 2011)

Sardar Patel University, Vidhyanagar, India

Courses: Pharmaceutical Analysis, Pharmaceutical Engineering, Pharmaceutical Chemistry,

Pharmacology and Toxicology, Medicinal Chemistry.

AREAS OF EXPERTISE

-Knowledge of Regulatory Guidelines viz. cGxP & ICH guidelines.

-Good understanding of eCTD, ANDA and NDA submission requirements, and FDA guidance documents.

-Good understanding of manufacturing processes.

-Proficient in literature survey using Online Journals, scifinder® (Scientific Chemistry Database, CAS, USA),

Pharma Projects, Patent Databases of Different Countries.

-Proficient with Microsoft office, Outlook, and Adobe Acrobat.

-Strong Communication, interpersonal and learning skills matched with the ability to manage multiple projects,

and timelines effectively.

PROFESSIONAL EXPERIENCE

Appco Pharmaceuticals, Regulatory Affairs/Quality Assurance Intern, New Jersey, USA (July 2016-present)

-Review batch production documents generated for manufacturing and packaging batch.

-Generate Vendor qualification compilation sheet

-Participate in investigation of change control, CAPA and Deviations.

-Prepare and maintain Quality Metrics

-Issue controlled copies of documents to require complying cGMP functions.

-Maintain master calibration records.

-Conduct QA inspection of in process batch.

-Sampling of raw material and exhibit batch for QC analysis.

-Stability program monitoring.

-Following Good Documentation Practices.

Indian Pharmaceutical Alliance (Zydus Cadila Group), Patent analyst, Ahmedabad, India (Aug 2013-May 2015)

-Scrutinizing and Scanning of Pharmaceutical Patent Applications filed in India.

-Prior Art search and Literature surveys.

-Drafting and Filing of Pre-Grant Oppositions for the appropriate Patent Offices in India.

Accutest Research Laboratories (CRO), Clinical Research Intern, Ahmedabad, India (Dec 2012-May 2013)

-Assist in screening of study subjects and filing Informed Consent Form.

-Participated in the team reviews of proposed studies.

-Tracked the progress of study by following up CRF, raw data query generation and resolution.

Shelter Pharma Ltd, Formulation Intern, Himmatnagar, India (Jun 2011-August 2011)

-Optimization of formulation composition to yield product suitable for oral administration.

-Preparation and communication of research results in both oral and written formats.

ACADEMIC PROJECTS

Project Management in Early Drug Discovery and Development (Apr 2016- May 2016)

-Practicing FDA Regulatory Guidelines for ANDA and NDA submission.

-Preparation of Regulatory Documents to support ANDA and NDA filing.

Bioequivalence study of orally administered Raloxifen 60 mg coated tablet in Normal, Healthy, Adult, Postmenopausal/Surgical Menopausal females, Human subjects under fasting condition. (Dec 2012-May 2013)

-Assist the CRA in protocol review for proposed study.

-Performed Pre-study, Initiation, Interim, and Close-out monitoring visits.

-Prepared and submitted documents required meeting the Regulatory and SOP requirements.

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