Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Timeline
Generic

SANTOSH KUMAR AVULA

Hyderabad

Summary

Dynamic Regulatory Affairs Professional with 9.6 years of experience, skilled in utilizing Veeva Vault to streamline regulatory compliance and optimize submission processes. Demonstrated expertise in leading cross-functional teams, resulting in enhanced productivity and successful strategic FDA submissions. Committed to fostering mentorship opportunities that drive project success and team development.

Overview

9
9
years of professional experience

Work History

Senior Regulatory Affairs Associate

Parexel International Ind PVT Ltd
06.2021 - Current
  • Improved compliance by overseeing regulatory portfolios of five projects with local and international regulations.
  • Increased efficiency by preparing and reviewing INDs, CTAs, MAAs, BLAs, and amendments with external partners.
  • Enhanced project communication by acting as the primary contact for regulatory agencies throughout project lifecycles.
  • Improved response times by handling FDA queries, including IR, CR, and DRL responses.
  • Streamlined submission process by compiling and submitting regulatory documents, including INDs, and NDAs.
  • Resulted in 100% compliance by leveraging electronic document management systems for eCTD submissions.
  • Increased team productivity by managing resources across 10 projects, ensuring deadlines were met.
  • Improved reporting accuracy by analyzing data and creating monthly utilization reports.
  • Enhanced team performance by providing direction to five junior associates on complex tasks.
  • Managed 200 binders while overseeing Veeva Vault document uploads.
  • Resolved submission-related issues while collaborating with onshore project coordinators.
  • Improved post-publishing activities through the management of inter-document hyperlinks.
  • Assessed current procedures and introduced enhancements that boosted productivity by 20%.

Associate Professional

DXC Technology India
09.2018 - 06.2021
  • Coordinated regulatory submissions across North America and Europe.
  • Achieved compliance by dispatching submissions to the US and CA, adhering to Regulatory Operations practices.
  • Optimized submission processes by emphasizing program management.
  • Reduced review time by 2 hours per submission, enhancing document review processes.
  • Updated training materials consistently to align with global regulatory submission standards.

Senior Executive

Aurobindo Pharma Limited
12.2017 - 09.2018
  • Compiled Regulatory Commitment Packages (RCP) and addendums.
  • Ensured timely communication by notifying the GPV Department post-product approval to stakeholders.
  • Increased industry visibility through monitoring eDrug listings effectively.
  • Created new SPL formats, and made corrections to existing formats.

Senior Associate

Accenture Accelerated R&D Services
10.2016 - 10.2017
  • Successfully managed 8 projects efficiently, meeting 100% of milestones.
  • Achieved publication quality by performing peer reviews on Clinical Study Reports and Investigator's Brochures.
  • Streamlined FDA regulatory publishing for submissions, including INDs and NDAs.
  • Increased team accountability by managing resources effectively across five teams.
  • Created reports for senior management through data analysis.

Associate

Freyr Global regulatory solutions
08.2015 - 09.2016
  • Managed post-publishing activities including inter-document hyperlinks.
  • Conducted quality control checks to maintain superior submission standards.

Education

Masters - Pharmaceutical Management and Regulatory affairs

JNTU

Bachelor’s - pharmacy

OU

Skills

  • Veeva Vault
  • TRS Toolbox
  • Lorenz Docubridge
  • ECTD Express
  • ECTD Viewer
  • ECTD Manager
  • Pharma ready
  • Viewpoint
  • Insight Publisher
  • Calyx
  • CARA
  • Regulatory submissions
  • FDA regulations
  • Regulatory strategy
  • Product lifecycle management
  • Training and mentoring

Websites

Accomplishments

    Independently Handled and Filed 5 original IND, 2 original ANDA, and One FTF Successfully Without Any RTR and got Approvals for the same.

Timeline

Senior Regulatory Affairs Associate

Parexel International Ind PVT Ltd
06.2021 - Current

Associate Professional

DXC Technology India
09.2018 - 06.2021

Senior Executive

Aurobindo Pharma Limited
12.2017 - 09.2018

Senior Associate

Accenture Accelerated R&D Services
10.2016 - 10.2017

Associate

Freyr Global regulatory solutions
08.2015 - 09.2016

Masters - Pharmaceutical Management and Regulatory affairs

JNTU

Bachelor’s - pharmacy

OU

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