Summary
Work History
Education
Skills
Software
Certification
Timeline
Tools
Tools
Overview
Generic
Prathyusha Kona

Prathyusha Kona

Regulatory Professional I
Bengaluru

Summary

To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Work History

Regulatory Professional I

Novo Nordisk
Bengaluru
05.2018 - Current
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Passionate about learning and committed to continual improvement.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Learned and adapted quickly to new technology and software applications.
  • Organized and detail-oriented with a strong work ethic.
  • Responsible for compilation and Publishing Marketing Authorization Applications/Life Cycle Management Applications to European (CP) /Swiss medic, GCC, Thailand, Australian, South African/ASEAN/ROW Health Authorities.
  • As Process Change Champion responsible for providing training on Veeva Vault to the world-wide affiliates
  • Responsible for SharePoint Page Creation & Mentoring, Onboarding the new joiners

Intern Trainee

Apotex Research Pvt Ltd, Bangalore
Bengaluru
06.2017 - 04.2018
  • Completed research, compiled data, and assisted in timely reporting.
  • Analyzed problems and worked with teams to develop solutions.
  • Participated in workshops and presentations related to projects to gain knowledge.
  • I was brought on onboard to handle labeling activities as well as in assisting CMC team members (Initial Submissions, Deficiencies & life cycle for US & Canada Markets)
  • Helped in reducing deficiencies by 50% by analyzing deficiency trends and revising templates accordingly.
  • Handling of Structured Product Labeling Submissions using SPL Form’s and Pragmatic validator.
  • Identify supporting documents required for submissions / deficiencies and negotiate timely delivery from cross - functional teams.
  • Co-ordinate with Quality control & assurance departments for the technical documentation required for dossier.
  • Basic knowledge in archiving and management of regulatory submissions data, in the form of electronic using Regulatory Information Management System (RIMS)

Education

Bachelor of Pharmacy -

Raghavendra Institute Of Pharmaceutical Education
08.2012 - 06.2016

Master of Pharmacy - Pharmaceutical Quality Assurance

Manipal College Of Pharmaceutical Sciences
Manipal
08.2016 - 06.2018

Skills

    Regulatory filings and compliance

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Software

MS Excel

MS PowerPoint

Certification

Six Sigma Yellow Belt

Timeline

Regulatory Professional I

Novo Nordisk
05.2018 - Current

Intern Trainee

Apotex Research Pvt Ltd, Bangalore
06.2017 - 04.2018

Master of Pharmacy - Pharmaceutical Quality Assurance

Manipal College Of Pharmaceutical Sciences
08.2016 - 06.2018

Bachelor of Pharmacy -

Raghavendra Institute Of Pharmaceutical Education
08.2012 - 06.2016

Tools

 Lorenz docubridge, Liquent Insight Publisher,  ISI Toolbox, Pragmatic validator, EURS eValidator, Lorenz eValidator,  Bosnia Nees Checker, First Doc, Veeva Vault. Liquent Viewer 

Tools

 Lorenz docubridge, Liquent Insight Publisher,  ISI Toolbox, Pragmatic validator, EURS eValidator, Lorenz eValidator,  Bosnia Nees Checker, First Doc, Veeva Vault. Liquent Viewer 

Overview

6
6
years of professional experience
6
6
years of post-secondary education
1
1
Certificate

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Prathyusha KonaRegulatory Professional I