MANASA SURVI

acfjv3@r.postjobfree.com #**C Mc Greevey Way, Boston, MA-02120 Ph: 617-***-****

SKILLS

• Working knowledge of regulatory authorities like FDA, EMA, Health Canada & TGA, e-CTD submission,

GHTF/IMDRF guidances, ICH guidelines, proficient with criteria for clinical trials & clinical laboratory sample

management

• Understanding of US Title 21 CFR 50 (Protection of Human Subjects), 54 (Financial disclosure by clinical

investigator), 56 (IRB & IRB submission procedures ), 58 (GLP for non clinical laboratory studies), 210 & 211

(cGMPs for Pharmaceuticals), 600-640 (Biologic Product labeling & licensing regulations), CMC sections and

regulatory procedures

• Familiar with CAPA, ISO 13485, ISO 14971, Premarket notification (510k), PMA, US, Canadian & Australian

medical device regulations, medical device reporting and Quality System Regulations

• Experience working with Microsoft Office (Word, Excel & Power point) and knowledgeable in SQL server

• Self motivated and detail oriented person willing to learn and grow, team worker demonstrating excellent

communication skills, strategic planning, organizational and multitasking skills

EDUCATION

NORTHEASTERN UNIVERSITY

College of Professional Studies Boston, MA

Master of Science in Regulatory Affairs Candidate (3.54) Expected 2015

M.R.R COLLEGE OF B.PHARMACY Hyderabad, INDIA

Bachelors in Pharmacy June 2011

PROJECTS

NORTHEASTERN UNIVERSITY Boston, MA

Regulatory License Submission for a Canadian Medical Device Apr-June 2014

• Prepared and documented marketing license application for a Class II Canadian patient monitoring device

Regulatory overview of the Biologic Product (Gintuit TM) Feb-Mar 2014

• Compilation of regulatory information & pertinent

documents and submitted Biologic License Application, reviewed 21 CFR 600-680 and Form 356h section analysis for Gintuit

Product Development of a Medical Device Jan-Mar 2014

• Provided regulatory assistance to the team throughout the

design control phases for EU submission of an A-Fibrillation Ablation Catheter having a CE mark

Regulatory approval for the drug Sep-Dec 2013

• Coordinated, reviewed 21 CFR 314 & 314 and simulated

submission of IND application, New Drug Application for marketing smoking cessation drug, Chantix

Presentation on FDA Recent Guidance and Information on Mobile Medical Applications Oct 2013

• Described manufacturing, quality system regulations,

device reporting, and use of Mobile Medical Applications

MYLAN LABS (MATRIX LABORATORIES LIMITED) Hyderabad, INDIA

Project Trainee in Quality Assurance (QA) Feb-Mar 2011

• Challenged with work ethics to document data & processes for intellectual property protection and successfully submitted a project on Guide for Pharmaceutical Dosage Form Specification

• Knowledgeable in quality specifications for pharmaceutical products, excipients and dosage forms and activities related to overall quality control and assurance to produce safe and effective pharmaceuticals

• Referred to documentary, monographs, reference standards, ICH guidelines, residual solvents, SOPs specific to the company and pharmaceutical industry

• Compiled stability tests for solid, semisolid and liquid forms and documented the comparison of specifications for various dosage forms from USP-NF, EP, BP, JP and IP

SRI KRISHNA PHARMACEUTICALS Hyderabad, INDIA

Industrial trainee in Quality Control (QC) Jun–Jul 2010

• Gained in depth knowledge on Good Manufacturing Practices (GMPs), Good Laboratory Practices

(GLPs), handling instruments like HPLC, TLC, disintegration and dissolution apparatus

• Prepared chemical reagents, performed stability tests, detected impurities and reported deviations, interpreted basic data, maintained log books, compiled and documented activities to meet deadlines

• Referred standard operating procedures (SOPs), guidelines and carried out activities as directed by the trainer

WORKSHOPS

NIPER-HYD IN COLLABORATION WITH NOVARTIS Hyderabad, INDIA

Drug Development: Conceptualisation to Commercialisation Aug-Oct 2012

• Conceptual overview of Pharmacovigilance, Clinical

trials, Drug development process, Regulatory Affairs

• Prepared sample Case Report Forms (CRFs), Informed

Consent Document, identified & reported adverse events, submitted sample SOP documents and reviewed product labels with CTD sections

NORTHEASTERN UNIVERSITY Boston, MA

2014 CPS Second Annual Case Writing Competition (Next Generation GERD Device: A Case Study) Feb-Apr 2014

• Authored and successfully submitted a Case & Case

Analysis on a fictional medical device for the warning letter received from the FDA

• Focused on problem solving & critical thinking skills,

analyzed the cause and developed solutions to prevent occurring the same in future

Certificate of Participation in International Student Job Search Forum Mar 2014

OTHER ACTIVITIES

• Secretary & Volunteer coordinator for Pediatric Brain Tumor Foundation- Starry Night, Boston

Dec 2013-Present

• Working as a Residential Safety Office Proctor at Northeastern University

Jul 2013-Present

Assisting the residents, providing customer service, attending phone calls, reporting the safety to the supervisors

and University police

• Volunteered for Research Innovation Scholarship Expo poster presentation- RISE 2014

Apr 2014

• Henna artist volunteer at Northeastern University for

International Student Scholar Institute (ISSI) Carnevale Feb-Mar 2014

International Education Week cultural celebration (IEW-13) Nov-2013

• American Red Cross Boston Food Pantry- voluntarily assisted with packaging and distribution of food

May 2013

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