Project Management, Regulatory affairs, Quality control.

RASHMI ARRAGUNTA

**C Smith Street, Boston https://www.linkedin.com/in/rashmiarraguta

+1-617-***-**** *********.*@*****.***.***

Education

Northeastern University, Boston, MA July 2019*

Master of Science in Project Management with a customized concentration in Regulatory Affairs. GPA 3.5 Relevant Coursework:

FDA Pharma Regulations of Drugs, Biologics and Medical devices, Human Experimentation, Medical Device Development, Foundations of Project Management, Project Management Practices, and Project Scope Management. Prin.K.M. Kundnani College of Pharmacy, University of Mumbai, Mumbai, India. July 2017 Bachelor of Pharmacy

Work Experience

Pharmadeep Remedies, Private Limited., Hyderabad, India May 2016 – June 2016 Regulatory Affairs Intern

• Analyzed the adverse events, medical device reports and compliance reports for a drug.

• Assisted in projects, submissions, and documentation in drugs approval process.

• Performed the qualitative and quantitative analysis of the drug.

• Inspected the cGMP process during the development life cycle.

• Surveyed the Post-Marketing Surveillance of the drug. Academic Skills

o Practical and academic experience in FDA Pharma regulations. (21CFR 820, 210, 211, 300-399, 600-699) o Knowledge about Drugs and Biologic’s approval processes – Investigational New Drug (IND), New Drug Application (NDA), Investigational Device Exemption (IDE), and Abbreviated New Drug Application (ANDA). o Knowledge about Medical Device approval processes – Pre-Market notification, 510(k), Post-Market Approval. o Knowledge in cGMP, cGLP, cGCP, QSR, design controls. o Proficient practical experience in MS office -MS Word, Power point, Excel, MS Project. o Effective Communication, confident speaker and good listener. o Presentation skills, team player, multi-tasker.

Academic Projects

• Tool for Amazon Go:

o Developed a tool using Microsoft Project which performs Budgeting, Scheduling and Scope analysis of the Amazon Go.

o Performed in-depth analysis of the data using the Network Diagram which was the base for estimating and as an input to the above activities.

• Regulatory pathway for Appliance Facial Fracture External: o Outlined a strategic regulatory pathway for a Class 1 medical device using 510(k) pre-market notifications.

• Analyzed the business requirements, functional and non-funcional requirements of the PMI’s case studies and prepared the requirement traceability matrix (RTM) for the same.

• Practically demonstrated the medical device Capillus Pro 272 along the regulatory pathway with the help of a physical device. Interests

• A member of the Student council as the Ladies Representative in undergraduate school.

• The Editor and Event Manager of Clinical Community Pharmacy Cell (Non-profit organization) in Mumbai.

• Active member of Regulatory Affairs Professional Society (RAPS) and Project Management Institute (PMI).

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