Regulatory Affairs with 4.5 years pharmaceutical industry experience.

PRIYANKA P. GHULE

**** ******** ******, ***#**, Boston, MA02215 ac0soe@r.postjobfree.com +1-901-***-**** CORE COMPETENCIES

Combined experience in R&D and as patent analyst Cross functional teamwork ability Ability to prioritize deadline in high impact environment Ability to handle multiple tasks/projects EDUCATION

Northeastern University, Boston, MA Expected July 2018 M.S. in Regulatory Affairs with specialization in Operational Regulatory Affairs (GPA -3.92) NMIMS University’s School of Pharmacy and Technology Management, Mumbai, India July 2011 Master of Pharmacy in Quality Assurance with Thesis

“Studies on Determination of Protein Binding using a cocktail approach” Mumbai University, Mumbai, India July 2009

Bachelor of Pharmacy

ACADEMIC PROJECTS AND COURSES TAKEN

1) Drug and Biologic Development: A regulatory overview

Well versed with NDA, BLA and IND submission requirement for drugs and biologics, NDA review and approval process, Pediatric study initiatives and fast- track and orphan drug designation.

Authored paper on information related to pharmacologic, non-clinical, CMC section of a drug and a biologic from Drugs@ FDA. Analysis of warning letter from FDA and drafting of a cover letter for NDA supplement. 2) Human Experimentation

Knowledgeable about criteria for participation of human subjects in clinical trials, designing of clinical trials IRB, informed consent, liaison between FDA, sponsor and clinical trial site, clinical trial documentation requirement. 3) Medical device development: A Regulatory Overview

Well versed with medical device regulation, QSR, De Novo Submissions, Humanitarian Device Exemption, 510(k) and PMA submissions and 21 CFR820.30, 510(k) and PMA database. 4) Experiential network Project- Virtual based project for Velocity Pharma LLC.

Regulatory Strategy Development for Diclofenac Patch for the UK, Europe Market 5) European Union Compliance and Regulatory Affairs for Medical Devices and Drugs

Knowledgeable about CE marking, New Medical Device Regulation 2017/745, Notified bodies, and classification of medical devices in EU, MAA procedure in EU.

Authored a Regulatory Strategy paper for marketing of Medical Device in France according to the new MDR 2017/745 EXPERIENCE

1) Sun Pharmaceuticals, Mumbai India Nov2013-Dec2015 Patent Analyst

Drafted Patents for various jurisdictions (US, EP, IN)

Reviewed and studied patents related to drugs(formulation) and medical devices

Performed patent prosecution activities, office action correspondence, and patent maintenance with various patent offices. (USPTO, EMEA)

Conducted prior art searches and prepared patent evaluation and patentability opinion report

Performed Due-diligence-monitoring of orange book updates 2) Biocon-Bristol Myers Squibb (BBRC), Bangalore, India Apr2012- Nov 2013 Senior Research Associate, Drug Metabolism and Pharmacokinetic (DMPK)

Performed Bioanalytical (LC-MS-MS) analysis of samples for various projects

Performed tissue distribution studies, plasma stability, microsomal stability studies, and protein binding studies

Awarded Biocon BMS R&D Star Award in 2013 for contribution towards a crucial project 3) Piramal Healthcare, Mumbai, India Jul2011- Mar 2012 Intern-Analytical Department

Worked in a GLP analytical laboratory with documentation requirements

Performed stability studies, analytical method validation and impurity profiling of injectables

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