Medical Device Regulatory affairs Human Resource

Disha Kabrawala

E-Mail: *********@*****.***, *****.*********@**.***.*** Contact: 732-***-****

Objective:

Energetic and highly motivated regulatory professional with strong multitasking and problem-solving skills. Strong understanding of drug and medical device regulatory submissions: IND, NDA, BLA, 510 (k), PMA. Currently seeking a full-time position in the RA/QA department that provides me with opportunities to show my skills, understanding and experience while contributing positively to the company.

Executive Summary:

Professional experience in Pharmaceutical industry in Regulatory Affairs and Quality Assurance department with strong Business Skills.

Knowledge of function and role of different regulatory authorities such as USFDA, MHRA.

Strong understanding of Regulatory submissions for drug and medical device IND, NDA, BLA, PMA, IDEs, eCTD as well as 510k

Knowledge of Title 21 of CFR (Parts 11, 50, 56, 201, 202, 211, 212, 312, 314, 820).

Comprehensive knowledge of NDA, ANDA, market exclusivity, FDAAA, FDAMA and FDASIA, CDRH's initiatives and product development protocol and review processes.

Well versed with FDA regulations for labeling, advertising-promotional material for products, OPDP regulations.

Efficient with guidelines associated with medical device filing including Premarket Notification 510(k), Investigational Device Exemption (IDE) and Medical Device Reporting (MDR)

Knowledge of Regulations for OTC Drugs and Medical devices, CMC, ICH Guidelines; cGMP, GLP, GCP, GDP,CBE 30

Excellent record keeping, written/oral communication and presentation skills and ability to work with cross-functional project teams

Professional Work Experience:

Regulatory Affairs Associate (Hips and Extremities) May 2018 - Present

Zimmer Biomet, IN

Design control and inputs

Contributes to the FDA regulatory submission process

Assists in the development of dossiers for registration of products in countries outside the US, including authoring and/or publishing electronic submissions(Review of Verification reports and protocols)

Provide regulatory guidance to development project teams as a core team member

Reviews labelling, including package inserts and surgical techniques for compliance with applicable US and international regulations

Verification of Design Output documents, product specifications (Package Insert reconciliation, Labelling Verification, Standards, Compatibility pull out for CAPA )

Reviews product changes for impact on regulatory status of the product (Verification of various regulatory process)

Reviews existing documentation and documents findings

Research Assistant May 2017- Dec 2017

Long Island University, NY

Hurdles in Biomarker and Invitro Diagnostics and Implementation of an efficient Global Regulatory affairs

Planned regulatory strategy for a companion Diagnostic for different countries

Worked on design and development planning challenges for medical device

Teaching Assistant Sep 2016 – Dec 2017

School of Pharmacy, Long Island University, NY

Conducting Classes of Pharmacy school

Grading of students

Database management

Administrative Assistant Mar 2016 - May 2016

Higher education opportunity program, Long Island University, NY

Database management

Managed application procedure of students

H.R Associate Mar 2013 – Oct 2015

Shri R. B. Shah Mahavir super Speciality Hospital, India

Administrative procedures regarding employee

Interaction with different departments for payroll and different benefits of employees

Verification procedure as per legal standards for employees (newly Intern or recruited)

Look after of medical benefits of employee

Complete all required procedures in a timely manner (training, induction, payroll, enrolment of staffs, medical benefits)

Look after of NABH guidance and application at hospital

Jr. Quality Assurance/Regulatory Analyst May 2011 Aug 2011

Vapi Care Pharma Pvt Ltd, India

Responsible for inspection of manufacturing equipment on daily basis (gauges, calipers, voltmeter, tablet count machine) for safe and efficient operations

Involved in raw material, chemicals, buffer and media preparation as per guidelines

Performed assays and various standardized tests as per lab protocols

Generated Standard Operating Procedure(SOP’s) as needed for regulatory group

Involved in team of ANDA filings, documentation and submissions

Reviewing of product labelling

Involved in the team of regulatory affairs strategy

Regulatory Intern May 2010 Aug 2010

Lincoln Pharmaceuticals Ltd, India

Involved in FDA Application( IND, ANDA,510(k)) submission and documentation of annual reports

Recorded and documented compliance reports with post marketing correspondence

Involved in creating structure, compile, reviewing of technical documents. Involved with the team of submitting ANDA, Supplement, Annual Reports

Education:

Master of Science -Major: DRUG REGULATORY AFFAIRS Jan 2016 – Dec 2017

Long Island University, USA

Masters of Business Administration-Major: HUMAN RESOURCE MANAGEMENT

S.R. Luthra Institute of Management, India Sep-2011- May 2013

Bachelor of Pharmacy – Major: PHARMACEUTICAL SCIENCES

C. K. Pithawalla Institute of Pharmaceutical Science and Research, India Sep 2007 – May 2011

Scholarships and Achievements:

Total scholarship of $27000 at Long Island University (Since Fall 2016)

Successfully audited NABH (National Accreditation board for Hospitals and Healthcare providers) certificate for Mahavir Super Specialty Hospital

Projects:

Research Project May 2017- Dec 2017

Project 1: Hurdles in Biomarker and Invitro Diagnostics and Implementation of a successful Global Regulatory affairs

Summer project

Read CMC guidelines and made presentations

Systematic review research on as a volunteer work

Curricular Projects

Regulatory Affairs Intelligence: Introduction, process, merits and demerits (Spring 2016)

Filing of NDA for FDA, Preparation of MOCK IND (Fall 2016)

Prepared and presented five IND modules for a given drug as a team work

Familiar with FDA requirements for IND submission, prepared requirements for pre-clinical meetings

Corrective and Preventive Actions (CAPA) for pharmaceutical company regarding quality assurance related voluntary drug recall case followed by implementation of new QMS (Quality Management System) (Spring 2017)

Employee Engagement May 2012 Jul 2012

Human Resource Management, KRIBHCO (Krishik Bharti Coop Ltd)

Profile as Trainee:

Surveyed of different cadre employees

Studied the job satisfaction level of employees

Supervised the facilities and benefits given to the employees

Undergraduate thesis – ‘Gene silencing Process on RNA and DNA’ Jan 2011 - May 2011

Investigated the regulation of oncogene expression mediated by a glutathione S-transferase gene (GSTP1) carcinogen

Certification and License:

RPh (Registered Pharmacist) by Gujarat State Pharmacy Council, India

Master of Business Administration in Human Resource Management

Software Competency:

Applications: Microsoft Office Products (MS Word, MS Excel, MS PowerPoint, MS Outlook, MS Access, MS SharePoint), Adobe Acrobat

Database: PubMed (Literature), eCTDxpress

Skills and other experiences:

Strong oral and written communication skill

Active member of AAPS student chapter of Long Island University

Invented and implemented performance appraisal method as HR associate

Enacted compulsory employee’s annual health check-up program

Served as leader of training and orientation of employees at SRBSM Hospital

Volunteered as counselor for employees at SRBSM Hospital

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