Summary
Overview
Work History
Education
Skills
Projects
Publications
Accomplishments
Languages
Hobbies and Personal Interests
Personality Traits
Timeline
Generic

Mahesh Engu

Hyderabad

Summary

Regulatory professional with extensive experience at Sandoz, specializing in compiling and submitting compliant regulatory dossiers across multiple regions. Proficient in Veeva Vault and data analysis, ensuring quality and accuracy in documentation. Proven track record of driving successful submissions and fostering collaboration among cross-functional teams.

Overview

12
12
years of professional experience

Work History

Manager, RegOPS Publishing

Sandoz
Hyderabad
04.2020 - Current
  • Compiled and submitted regulatory dossiers for multiple EU countries, ensuring compliance with registration procedures.
  • Managed submissions and response phases, diligently tracking progress throughout the process.
  • Prepared Module 1 documentation for Initial and RUP submissions to uphold regulatory standards.
  • Utilized data management tools, including SAP RegDB and Veeva Vault, for efficient regulatory information handling.
  • Executed MA transfer submissions, facilitating smooth transitions within regulatory frameworks.
  • Conducted quality checks on documents to verify adherence to regulatory standards.
  • Provided approved documentation for launch activities as part of QA package team.
  • Served as primary contact for SARA rendition issues, supporting submission-related tasks as necessary.

Regulatory Executive

Gland Pharma Limited
Hyderabad
08.2018 - 04.2020
  • Compiled and submitted regulatory dossiers, renewal documents, and post-approval changes for injectables.
  • Liaised with Plant, R&D, QA, and QC departments to secure essential documentation.
  • Reviewed customer and MOH queries during registration and product life cycle for timely resolution.
  • Ensured compliance with regulatory requirements specific to ASEAN region.
  • Evaluated and approved change control notices to uphold operational integrity.
  • Prepared and reviewed labeling documents in accordance with registration standards.
  • Managed tender requirements, questionnaires, and technical agreements efficiently.

Senior Regulatory Associate

Mylan Laboratories
Bangalore
04.2016 - 08.2018
  • Published various regulatory submissions for countries including US, AU, NZ, and Europe.
  • Ensured regulatory compliance by applying guidelines during pre-publishing of documents.
  • Validated submissions using multiple validation tools for accuracy.
  • Conducted quality checks on documents to meet all regulatory requirements.

Clinical Publisher

Novo Nordisk GSC India Pvt. Ltd
Bangalore
04.2015 - 04.2016
  • Published clinical documents, including CSR’s, NSR’s, and IB’s.
  • Defined and optimized standards for high-quality regulatory document preparation through checklists and guidelines.
  • Created macro-enabled MS Word templates to enhance document efficiency.
  • Collaborated with global stakeholders to manage appendix-related documentation.
  • Delivered end-user support for First Doc to facilitate smooth operations.

Regulatory Publisher

Parexel International
Bangalore
05.2013 - 04.2015
  • Executed pre-publishing of regulatory documents to ensure compliance with guidelines and specifications.
  • Converted templates and formatted documents using Authoring Tools for improved presentation.
  • Published submissions across various EU nations by adhering to National, Mutual Recognition, and Centralized Procedures.
  • Validated submissions through diverse validation tools to maintain accuracy.
  • Managed publishing of submissions in multiple formats, including eCTD, NeeS, and Paper.
  • Handled paper publishing for ROW to file MAA dossiers efficiently.
  • Conducted quality checks on documents to meet regulatory requirements.

Education

M. Pharmacy - Regulatory Affairs

JSS College of Pharmacy
Mysore, Karnataka, India
04-2013

B. Pharmacy -

Visveswarapura Institute of Pharmaceutical Science
Bengaluru, Karnataka, India
08-2010

Skills

  • ISI Toolbox
  • Lorenz Docubridge
  • eCTDXpress
  • Documentum
  • Veeva Vault RIMS
  • Adobe Acrobat Pro
  • Microsoft Office Suite
  • Data research and analysis

Projects

During my M.Pharmacy, I worked on an extensive project named 'Registration Requirements for Generic Drugs in South Africa' at Medreich Ltd, Bengaluru, for a period of six months. During the period of pursuing my thesis, I gained good knowledge regarding the compilation of dossiers for various countries, along with CTD requirements. During the same period, I also compiled dossiers for South Africa and ASEAN (Association of South East Asian Nations). I also excelled in the field of reviewing PILs and labeling artworks

During my B.Pharmacy program, I underwent training at 'SPRINKA PHARMA' in Hyderabad for 30 days in this period, I have undergone good training regarding the manufacturing of beta-lactam antibiotics, with special light being thrown on punching and also its blister packing

Publications

Published an article on the topic "Regulatory aspects of drug stability studies"  in IJRPS issue II

Accomplishments

  • Presented a poster on “Registration Procedure and Requirements for Dossier Compilation for Generics in South Africa” at OMICS, Hyderabad.
  • Presented a poster on “MedDRA” (Medical dictionary for regulatory activities) at IPC Bengaluru, 2011.
  • Presented a poster on 'Parkinsonism' at the IPA

Languages

Telugu
First Language
English
Advanced (C1)
C1
Hindi
Advanced (C1)
C1
Kannada
Intermediate (B1)
B1

Hobbies and Personal Interests

Cooking, listening to music, playing sports

Personality Traits

Curious, energetic, and friendly

Timeline

Manager, RegOPS Publishing

Sandoz
04.2020 - Current

Regulatory Executive

Gland Pharma Limited
08.2018 - 04.2020

Senior Regulatory Associate

Mylan Laboratories
04.2016 - 08.2018

Clinical Publisher

Novo Nordisk GSC India Pvt. Ltd
04.2015 - 04.2016

Regulatory Publisher

Parexel International
05.2013 - 04.2015

M. Pharmacy - Regulatory Affairs

JSS College of Pharmacy

B. Pharmacy -

Visveswarapura Institute of Pharmaceutical Science

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