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