Medical Device Management

Khushbu Bhavsar

New Jersey - *****

Phone: 917-***-**** E-mail: *********@*****.***

Career-Objective: Build a career in challenging and dynamic environment where I can utilize my

education and work experience in a productive manner to contribute towards my success as well as the

success of the organization.

Profile:

• Master of science in Drug Regulatory Affairs, Northeastern University

• Master of Business Administration (Project management as major), Gujarat Technical University

• Bachelor of Pharmacy, LM College of Pharmacy, Gujarat University

• Regulatory Affairs Intern (Northeastern University)

• Regulatory Affairs Assistant at Tripada Pvt. Ltd.

• Regulatory Document specialist at GIPS

• Regulatory Affairs Intern (Tripada Healthcare)

• Marketing Intern at Adani Wilmar Ltd

• Pharmaceutical Intern at Autocare Lifesciences Ltd.

Skills:

Regulatory and Pharmaceutical skills:

• Familiar with FDA regulations for drug development process

• Understanding of cGCP, cGLP and cGMP regulations

• Labeling requirement for drugs, medical device as per 21 CFR 801, advertising and promotional

requirements for drugs, biologics, and medical devices. FDA consulting meetings, post marketing

surveillance (Phase IV), pharmacovigilance

• Good understanding of Investigation New Drug Application, IND amendments (21CFR 312),

NDA (21CFR 314), CTD submission for NDA both paper and electronically, DMF, 510(k)

submission, PMA for marketing approval of medical devices, Biologics License Application (21

CFR 601), Labeling requirement for drugs, medical device as per 21 CFR 801, advertising and

promotional requirements for drugs, biologics, and medical devices.

• Special competency in the field of GLP, GCP, cGMP, QSR (21 CFR 820), ICH guidelines for

assuring safety, ISO 13485, ISO 9001, CAPA, REMS

Management skills:

• Communication - Deals with internal and external customers at different levels to ensure

successful communication via actively listening and probing questions.

• Project Management: PERT CPM

• Problem solving - Resolves in-depth queries in a methodical manner independently and with

internal and external business partners to find appropriate resolutions, efficiencies and high level of

quality.

• Team Player - Sharing of knowledge and encouraging development of others to achieve specific

team goals.

• Planning and organizing - Refined planning and organizational skills that balance work, team

support and ad-hoc responsibilities in a timely and professional manner.

Computer skills: Advanced Microsoft Office, basic of Clinical Trail Management system software

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Work Experience:

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Regulatory Affairs Intern (Northeastern University) January 14 – June 14

• Working on regulatory projects: Analysis of FDA Form 483 Issued to various companies.

• Documentation and study of Guidance published on Medical device and Drug.

• Study on pharmaceutical companies facing Regulatory Challenges and their inclination towards

acquisitions, mergers and alliances.

• Analyze form 356h Submission of cellular gene therapeutic products.

Regulatory Affairs Assistant (Tripada Healthcare Pvt. Ltd) Oct 12 – May 13

Preparation of regulatory submissions, Including Formatting and compilation of submission

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documentation, preparation of regulatory Components

Established submission timelines and manage information required to meet submission target

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dates.

• Work with the Drug Safety Response Center (DSRC), monitoring and sending of follow-up letters

and give support to pharmacovigilance team

Responsible for upload, retrieval and maintenance of documents for electronic submissions.

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Ensured proper maintenance and filing of regulatory related documentation and track regulatory

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commitments, submission requests, timelines and deliverables.

Interacted with cross-functional groups and attend team meeting as necessary to support

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submission development and project coordination.

• Regularly interacted with various internal departments in order to communicate regulatory

requirements and availability of regulatory documents.

Regulatory Document specialist (Gujarat Institute of Psychological Science and Research center )

May 12- Sep 12

• Maintain a database that records details of clinical trial shipments, and in collaboration with the

clinical research associates to ensure that there are adequate supplies of clinical trial material to

meet project needs plan, order and distribute non-drug clinical trial supplies

• Collect, supervise and maintain regulatory documents from clinical investigative site

• Review documents for compliance with regulations throughout the trial lifecycle, from initiation to

closeout

• Responsible for logging in received case report file (CRF) and transferring data from the CRFs

into the database.

• Preparation for the investigator study initiation meeting.

Regulatory Affairs officer (Tripada Healthcare) August ’11- April’ 12

• Coordinate with Development team to review all customer specific requirements for labeling and

packaging.

• Collaborated with project management to prioritize review of customer at work on daily basis and

sign off through changes management. Ensure labeling is in line with approved labeling.

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• Assisted in the clerical duties associated with regulatory Affairs

Marketing Intern (Adani Wilmar Ltd.) June’ 11 - July’ 11

• Work with managers to plan and direct the work of the organization.

• Help set policies.

• Evaluate work output.

• Work with and through management to develop and implement actions that protect company assets

and profitability.

Pharmaceutical intern at Autocare Lifesciences Ltd. April’ 10 – July’ 10

• Plan, implement, or maintain procedures for mixing, packaging, and labeling pharmaceuticals,

according to policy and legal requirements, to ensure quality, security, and proper disposal.

• Provide information and advice regarding drug interactions, side effects, dosage, and proper

medication storage

Education:

Master of Science (MS) in Regulatory Affairs in Drugs, Biologics and Medical device

Northeastern University, Boston, MA, US. (Expected graduation date- December 2014)

(Current GPA 3.5)

• Relevant Coursework: New Drug Development, Human Experimentation: Methodological Issues

Fundamental to Clinical Trials, Advanced Writing on International Biomedical Topics, Drug and

Medical Device Regulation

• Projects:

• Paper presentation on Outsourcing Clinical Trials to India: A benefit and Risk Analysis

• Prepared submission of 356h form for cellular gene therapy product

• Prepared regulatory summary for Class II Medical device product

Master of Business Administration, Gujarat technical University, India. May -2012

(GPA-3.94)

• Relevant Coursework: International business Service and Relationship management, Brand and

Product management, Project management, Supply and Distribution management, Advertising and

Promotion, Strategic management, Consumer behavior

• Projects:

Consumer behavior towards edible oil in modern format store

Global country report on Egypt

Bachelor of Pharmacy, LM College of Pharmacy, Gujarat University, India. May 2010

(GPA-3.75)

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• Relevant Coursework: Pharmaceutics, Pharmaceutical Analysis, Biotechnology, Medicinal

Chemistry, Pharmacology, Pharmacognosy, Pharmaceutical Engineering, Microbiology and

Anatomy & Physiology

Achievements:

• Participated as Delegate in the 60th Indian Pharmaceutical Congress held at New Delhi,

December-2008.

• Achieved SECOND RANK in competition on National Level Symposium for Pharmacy Students

Pharma-Fest–2009 in Poster Presentation on Microchip Based Drug Delivery System.

• Participation in Research Surveys for the Consumer products industries

• I was the active member of Event organizing committee in the College.

Additional Information:

• Capable to learn concepts quickly, communicating ideas clearly and effectively, and able to

associate with clients and management with positive attitude

• Willing to take responsibility outside typical scope of work.

• Excellent team building and management skills

• Self motivated and detail oriented

• Strong Written, Verbal communication skills

Reference: Available upon Request

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