Chemical Engineering Medical

ANUSHA GOPALAKRISHNAN

**** ** ***** **, *******, WA 98028 425-***-****

********@*****.*** https://linkedin.com/in/anushagk

Objective

Seeking a position in Regulatory Affairs with excellent potential for learning and growth.

Education

REGULATORY AFFAIRS CERTIFICATE: PHARMACEUTICALS AND DEVICES

OCT 2013 REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS)

Related coursework: Medical Devices & Pharmaceuticals – US Regulations, Global Regulatory Strategy – Medical Devices & Pharmaceuticals, Regulation: EU & US Biologics, Medical Devices & Pharmaceuticals: Definition & Lifecycle, Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Quality System Regulation, Introduction to Medical Writing, Ethics, Role of a Regulatory Professional.

M.S. CHEMICAL ENGINEERING DEC 2004 WAYNE STATE UNIVERSITY, MICHIGAN

Related coursework: Biochemistry, Introduction to Biomaterials, Biochemical Engineering, Bioremediation of Hazardous Wastes, Engineering Physiology, Tissue Engineering and Hybrid Systems.

B.TECH. CHEMICAL ENGINEERING JUN 2001 UNIVERSITY OF MADRAS, INDIA

Experience

SUPERVISOR & REGULATORY AFFAIRS SPECIALIST VENTRIPOINT INC. DEC 07 – JUN 09

Prepare regulatory documentation for Institutional Review Board (IRB) approval, IDE and the clinical trial sites in compliance with FDA regulations (medical device).

Create and maintain SOPs and cGMP for the project with feedback from the development team.

Research and implement requirements for clinical trials and submission approval in US and other countries.

Ensure that clinical trials are conducted in compliance with HIPAA and FDA regulations.

Secure and manage patient reports from the clinical trials.

Manage the Clinical Affairs and Research team in the absence of VP of Clinical Affairs.

Supervise the research team: assign tasks, track performance, ensure accuracy of work.

Maintain the database of Congenital Heart Disease (CHD)s, track the development of individual catalogs and help categorize newly acquired studies, train new hires on tracing protocol.

Process and trace MRI of hearts with congenital diseases as part of building the catalog database.

TECHNICAL CONSULTANT ELECTRICAL AND ELECTRONICS EQUIPMENTS LTD., INDIA MAY 05 – DEC 06

Worked on a project on field and dynamic balancing of unbalanced industrial equipment.

Developed software in MATLAB that calculates the imbalance parameters for the machinery being serviced using experimental data, and to recommend procedures to curb vibration.

RESEARCH ASSISTANT WAYNE STATE UNIVERSITY, MICHIGAN MAY 03 – FEB 04

Developed a reactor system for the remediation of Arsenic Trioxide from polluted ground water using a genetically engineered strain of Saccharomyces Cerevisiae.

Acquired practical knowledge of Cell harvest technologies, Cell culture and analysis using Inductively Coupled Plasma Mass Spectrometry.

Projects

BIOREMEDIATION Developed attenuation model for transport of dissolved hydrocarbon contaminants in ground water using Bioplume III package and proposed a remedial action plan for the system studied.

TISSUE ENGINEERING Analyzed the latest developments in the field of tissue engineering for cornea transplant and proposed a combination of techniques to develop a tissue-engineered cornea from human corneal stem cells; proposed methods to overcome the drawbacks of the currently available corneal transplant procedures.

BIOMATERIAL IMPLANTS Designed a Titanium based model for hip replacement in adults & studied the long-term performance of this model; designed a venous access port for chemotherapeutic drug delivery.

Internships

AMMONIUM PHOSPHATE SULFATE FERTILIZER PLANT, E.I.D. PARRY INDIA LTD.

Redesigned the catalytic bed converter to increase sulfuric acid production rate

Designed a tail-gas scrubber for efficient removal of sulfurous compounds from the exhaust fume

Proposed an enhanced agitation system for the oleum storage tank.

INDIAN ORGANIC CHEMICALS LTD., CHENNAI, INDIA – IN-PLANT TRAINING

Trained in the manufacturing process for Polyethylene Terephthalate (PET) fibers.

Conducted experiments for testing of new fiber blends developed by the R&D division.

Presentations and Awards

First Place for National Level paper presentation entitled ‘Immobilization of Enzymes’ at Dharmsinh Desai Institute of Technology(DDIT), Nadiad, India.

Presentation entitled ‘Degradation of Explosives – A Milestone in Biochemical Technology’, University of Madras, India.

Professional Memberships

Regulatory Affairs Professionals Society

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