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Regulatory Affairs

Location:
Plainsboro Township, NJ
Posted:
May 14, 2020

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Resume:

Prarthna Rakesh Painter

adc7pt@r.postjobfree.com 617-***-**** https://www.linkedin.com/in/prarthna-painter/

EDUCATION:

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices Jun 2019

Northeastern University- GPA 3.84/4.00

Bachelor of Pharmacy Jun 2017

Nirma University- GPA 3.67/4.00

EXPERIENCE:

Regulatory Affairs Specialist III (Contract) Apr 2020-Present

Becton Dickinson, USA

Working with various regulatory teams to solve regulatory queries and documentation requirements

Planning, coordinating and implementing international regulatory strategies for product submissions

Supporting IVD products registration for many different countries

Working for submissions product shipping release

Experience working on TrackWise and various other company specific software and tools

Maintaining and forming necessary regulatory documents for the product submission

Regulatory Publishing and Submission Specialist Sep 2019- Apr 2020

Freyr Solutions, USA

Publishing activities such as bookmarking, internal and external hyperlinking and validation of submissions

Working on various submission tools and performing quality control checks to deliver quality eCTD submissions

Preparing regulatory documents for eCTD/NeeS submission of IND, NDA, ANDA

Creating lifecycle submissions of drug products

Knowledge about regulatory domain for Canada, Europe, United States, ROW submission types, formats and process

Regulatory Affairs Intern Apr 2019-Jun 2019

scPharmaceuticals, USA.

Worked on a comprehensive project of a combination product labelling for European countries

Documented a detailed Packaging and Labelling Requirements Specifications (PLRS) for all the EU countries

Experienced in working with the label creation according to the EU MDR regulations

Assisted in working and discussing the UDI placement and application on the label/packaging

Assisted in classification and demarcation of the combination product for the European market

Revised ISO and CRF standards compliance for product package labelling for the USA market

Regulatory Affairs Intern Jan 2017-Dec 2017

Antila Lifesciences Pvt. Ltd., India

Reviewed and approved documents to determine compliance with regulatory regulations and standards

Supported the compilation and maintenance of regulatory filings, which aided in gaining knowledge of regulatory filing of IND, NDA, and ANDA

Maintained and reviewed audit reports, validation reports and formed template for clinical study report

Assisted in proofreading activities for regulatory documents for accuracy in English

Worked on Drug Master Files by working cross-functionally with other departments

VOLUNTEERING

Regulatory Affairs Consultant Sept 2019-Present

MoyoMedical Technologies, USA

Working with the company to prepare regulatory submission for marketing the device in the US market

Preparing for pre-RFD (Request for Designation) submission for classification of the medical device

Drafting a 510(k) application for the product to define a plan of action

Defining the stages of G(x)Ps documentation necessary for the approval of the product

SKILLS:

Regulatory Skills: Well versed with forms like 1571, 1572, 356h, 482, 483, 484, IDE, 510(k), PMA, supplements and amendments, protocol amendments, annual reports, ICH guidelines, IRB, CTAs, Guidance documents, SOPs, ICF, advertising and promotional labeling, CAPA, FMEA

Computer Skills: MS Word, MS PowerPoint, MS Excel, MS Visio, MS Project, TrackWise, SAP, SharePoint, Veeva, TrackWise, Accelrys, Publisher, docuBridge, ISI toolbox (Adobe Acrobat), Liquent IP, Lorenz Validator, pharmaREADY, CREDO



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