Aspiring Regulatory Affairs Professional

AKSHAY KULKARNI, MSRA

***********@*****.*** +1-857-***-****

https://www.linkedin.com/in/akshay-kulkarni-msra/

Competent QA/RA professional, with experience in post-market surveillance and looking to transition into regulatory submissions. Well-versed in clinical, pre-market, regulatory and quality requirements.

EXPERIENCE

Regulatory Affairs Intern, Lilu, Inc. April 2018 – June 2018

Devised a regulatory strategy for a de novo device in the markets of China, Hong Kong, and Taiwan.

Conducted market research in the maternal healthcare markets of China, Hong Kong, and Taiwan.

Instrumental in planning the marketing of the device globally.

Post-Market Vigilance Specialist, Medtronic September 2017 – April 2018

Drafting of MDRs for submission to US FDA.

Evaluation of incoming complaint information and determining reportability (MDR/AE) to FDA and other international agencies as a part of the Consumer Affairs team.

Instrumental in reducing the backlog of complaints by 50%.

Attend meetings with cross-functional teams to ensure proper communication and evaluation/ investigation of complaints.

Manage improvement tasks associated with vigilance reporting activity while ensuring full compliance with current and future regulatory requirements.

Administrative Assistant, Northeastern University October 2016 – August 2017

Displayed proficiency in MS Office for the purposes of documentation, invoicing, and handling of confidential information at the Kostas Nanotechnology Research Center.

Controlled purchasing, communicated with vendors and lab users, maintaining of lab conditions, and devised an inventory system which reduced expenditures significantly.

Management Trainee – Regulatory Affairs, Tidal Laboratories June 2015 – May 2016

Compilation and review of MAA applications for Indian generic products prepared for CDSCO submission. Coordinated drug supply and logistics.

EDUCATION

MS Regulatory Affairs, Northeastern University 2016 – 2018

US FDA, EMA, LATAM, HC, and other international regulatory bodies’ regulations and guidelines for medical products.

GXP document management and maintenance practices, SOP writing and review, validation and verification methods, risk management principles and methods, labeling regulations and guidelines.

Successfully completed individual and team projects, which included preparation of mock submissions like IND application, EOP-2 Meeting Request Letter, Biosimilar Development Plan, Regulatory Strategy for a biologic product in EU and more.

Bachelor of Pharmacy, University of Mumbai (India) 2011 – 2015

Learnt all aspects of product development, including medicinal chemistry, pharmaceutical sciences, pharm administration, pharmaceutical analysis, pharmacology, and quality assurance.

SKILLS

ICH Guidelines, Emerging Markets’ Regulations, CLIA Regulations, QSR, CAPA, IND, NDA, BLA, GMP, GCP, ICF, eTMF, ISO 13485, ISO 14791, ISO 9001

Sharepoint, EDMS, eCTDXpress, MS Office, MS Project, Adobe, Windows and Mac Operating Systems, DocuSign.

VOLUNTEER WORK

Student Mentor, Mentor Collective September 2017 – July 2018

Mentoring and providing guidance to new, international graduate students.

Tutor December 2015 – February 2016

Volunteered as an English tutor to middle-school students.

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