Human Resources Business Development
Resume:
Gouri Pattanshetti
Chesterbrook, PA ***** 215-***-**** *****.**@*****.***
https://www.linkedin.com/in/gouri-pattanshetti-47a32024b/
Technical Editing and Formatting Regulatory Affairs
Technology savvy regulatory affairs associate with 1 year of experience in filing high-quality regulatory submissions, interacting with regulatory agencies and project teams, concerning submissions, to ensure that all requirements are met. Eager to expand knowledge in emerging market trends.
Core Competencies
Business Analytics
Vendor Management
Stakeholder Management
Process Development
Requirements Analysis
Data Analysis & Reporting
Technology Integration
Operations Support
Proof reading
Quality Assurance
Relationship Building
Fact checking
Regulatory Submissions
Regulatory Research
Technical Editing
Forms management
Technical Skills: Microsoft Office - Word, Excel, PowerPoint, Toggl, Teams, Egnyte, SmartSheet, Adobe Acrobat, Visio, Jira, Lucid Charts, SQL.
EDUCATION & CREDENTIALS
Bachelor of Engineering in Information Science, Visveswaraiah Technological University
Training and Certification in Business Analysis and Software Quality Testing, Udemy
PROFESSIONAL EXPERIENCE
Technical Formatter Clementi & Associates, Bryn Mawr, PA 09/2023 – Current
Format documents intended for regulatory submissions in accordance with company style manual to ensure they meet requirements for electronic submissions.
Identify, obtain, compile and review regulatory documents for regulatory submissions, striving for quality submissions and expedited approvals.
Remain up-to-date with the latest changes in regulations and be able to assess and prepare amendments.
Coordinated the manual preparation of technically and scientifically complete document packages for submission to regulatory agencies.
Effectively communicate and collaborate effectively with other departments.
Perform document coordination and participate in project management activities.
Help prepare & maintain FDA regulatory documents with a team of others, as well as place them in eCTD.
Provide regulatory guidance, preparation and submission of CMC sections for IND, NDA, ANDA and supplemental filings.
Floating Para-Aid ESS, PA 09/2023 – Current
Currently working in a part time capacity in Tredyffrin and neighboring school districts (Mondays and Fridays).
Resourcing Support Executive Online Instruments India Private Limited, Bangalore, India 07/2010 – 03/2012
Documented quarterly and annual sales reports which included editing and proof reading, fact checking and formatting to help analyze profit margins, and shared with stakeholders.
Delivered next-level customer service to improve satisfaction, deploying high attention to detail and analytical skills to ensure smooth delivery of orders and following up with maintenance contracts with the clients.
Promoted continuous improvement and change management by evaluating business processes and developing action plans to optimize project delivery based on business outcomes.
Leveraged exceptional communication skills to foster relationships and coordinate with clients to place orders for audio-visual equipment and projectors; followed up with maintenance contracts with the clients.
Partnered with cross-functional team members and key decision-makers to provide administrative support across business operations, including scheduling meetings with employees and vendors.
Key role in distributing surveys to clients to gather feedback and identify needs; promoted business development by advising current and prospective customers on new products.
VOLUNTEER EXPERIENCE
Volunteer Tredyffrin Public Library, Chesterbrook, PA 03/2022 – 06/2022
Instrumental in promoting the mission of the organization while assisting staff with selling books on Amazon to reduce unused inventory and free space for new books.
Volunteer Valley Forge Middle School, Wayne, PA 06/2021
Responsible for assisting students with receiving their COVID-19 vaccinations by coordinating scheduling and responding to incoming inquiries.
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