Dileep Manthena
Hyderabad
Summary
Accomplished regulatory publishing professional with 11+ years of experience in managing global regulatory submissions for major health authorities, including the USFDA and EMA. Proven expertise in eCTDmanager, eCTDXpress, Veeva Vault, Docubridge, and Insight Publisher to ensure compliance and timely delivery of dossiers. Career goals include further enhancing regulatory submission processes to streamline regulatory operations and improve efficiency across global markets.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Manager
Tata Consultancy Services
Hyderabad
06.2025 - Current
- Led project teams to streamline client engagement strategies.
- Coordinated cross-functional collaboration to enhance service delivery.
- Developed training programs for team members on best practices.
- Analyzed client feedback to improve service offerings effectively.
- Monitored staff performance and addressed issues.
- Conducted regular meetings with staff to discuss progress and identify areas of improvement.
Consultant - RA Publishing
PAREXEL INTERNATIONAL
Remote
11.2020 - 06.2025
- Quality control of submissions, point of contact for the allocated shift, and training new joiners.
- Publishing and archiving of eCTD submissions for the US, EMA, Health Canada, and other global submissions using eCTDmanager, Veeva Vault, and submitting the same via Gateways.
- Worked for several clients, including Fresenius Kabi, Merck KGaA, and Amgen, with various publishing tools.
- Performing document-level activities such as PDF properties setup using SmartDesk, ISItoolbox.
Senior Specialist - RA Publisher (APAC)
MSD INTERNATIONAL GMBH
06.2018 - 08.2019
- Publishing NDA submissions (Insight Publisher tool) in the region and supporting the publishing work carried out by our decentralized publishing team who are working on dossiers for the region.
- Responsible for identifying and maintaining requirements supporting regulatory dossier assembly and delivery to regulatory health authorities or to the country organization in the region.
- Participate in system testing, performance measures and other efforts necessary for readiness.
Regulatory Publishing Specialist
ABBOTT PHARMACEUTICALS
Mumbai
06.2016 - 06.2018
- Responsible for uploading documents in DMS and publishing as per CTD, eCTD, NeeS, and ASEAN CTD format with eCTDXpress Publisher.
- Perform electronic and paper publishing tasks, including the initiation of events, creation of TOCs, compilation, publication, and validation of submissions.
- Maintain open, timely, and effective communication with all publishing contributors and the responsible RA professional to ensure the timely delivery of dossier
Executive - Regulatory Publishing
TEVA PHARMACEUTICALS INDIA PRIVATE LIMITED
Mumbai
06.2015 - 06.2016
- Regulatory Publishing activities for Variations, Renewals, Response to Questions, RFIs, ANDAs, and Periodic Safety Reports, Annual Reports in eCTD (majorly) and NeeS formats with Liquent Insight Publisher tool [DMS-Wisdom] and ADAM tool (INFOTECHNA).
- Perform document level publishing (ISI ToolBox) activities for EU and US FDA submissions, troubleshoot document issues and perform quality control checks for submission ready documents.
- Validating Published output with LORENZ and EURS Validators and uploading Submissions to respective Country portal through Common European Submission Portal (CESP) of eSubmission Gateway Web Client.
- Trained new joiners on Liquent Insight Publishing tool, DMS, Validation tools, etc.
Regulatory Publishing Trainee; Associate - II
NOVO NORDISK GLOBAL SERVICE CENTRE
Bangalore
11.2013 - 05.2015
- Global Submission Publishing (Liquent Insight Publisher [DMS- novoDOC]) of eCTD (Australia, Saudi Arabia), NeeS (Australia), Paper CTD (India), ASEANCTD (Singapore, Philippines, Thailand, Malaysia, Vietnam) from a global perspective.
- Post Publishing activities for published outputs with ISI ToolBox, Validating Submissions with EURS, LORENZ validators.
- Country Specific Regulatory Pre and Publishing activities for Brazil, Mexico submissions.
- PDF specification checks to ensure high quality in the documents.
- Completed the course certificate on ePUB (Liquent Insight) End User Training
Education
Master of Pharmacy - Drug Regulatory Affairs
Manipal University
01-2014
Bachelor of Pharmacy -
Vaagdevi Pharmacy College
01-2012
Intermediate (12th class) -
Narendra Co-operative Junior College
01-2007
Skills
- Management of global regulatory submissions (US, EMA, etc)
- eCTD 32, basics of eCTD 40
- NeeS and paper format publishing
- Veeva Vault, eCTDXpress, eCTDmanager, Docubridge, and Insight Publisher
- End-to-end regulatory publishing
- IST toolbox, Smart Desk
- EURS, Lorenz validators
- Health Authority portals and gateways
- Basics of word formatting
Projects
1. Robocopy application: Command prompt which speed-up the data transfer from one drive to another in quick manner.
2. Vendor Qualification for Paper Logistics (Novo Nordisk - cLEAN Six Sigma Project).
3. Management of global regulatory submissions (eCTD, NeeS, Australian paper CTD and ASEAN CTD) using electronic infrastructure.
Hobbies and Interests
- learner level - Pianist
- Watching documentaries
- Listening to music
Certification
- InSight Publisher Certified - Professional (LIQUENT InSight Certification Exam by PAREXEL International)
- CLEAN (Six Sigma) Academy 1 Star certified (Failure Modes and Effects Analysis, Root Cause Analysis)
- eCTD Overview and Submission certification (CDER-USFDA Web-Based Training course)
Achievements
- Annual award, 2022 (second place) at Parexel International
- Robocopy application development in-collaboration with IT department
Knowledge areas
- Strong knowledge of ICH guidelines (Quality, Safety, Efficacy and Multidisciplinary).
- Good understanding of New & Generic approval procedure of Pharmaceuticals /Biopharmaceuticals in United States, Europe, Australia
- Familiar with 21 CFR regulations, cGMP, Clinical trials, Pharmacovigilance activities, etc.
Timeline
Manager
Tata Consultancy Services
06.2025 - Current
Consultant - RA Publishing
PAREXEL INTERNATIONAL
11.2020 - 06.2025
Senior Specialist - RA Publisher (APAC)
MSD INTERNATIONAL GMBH
06.2018 - 08.2019
Regulatory Publishing Specialist
ABBOTT PHARMACEUTICALS
06.2016 - 06.2018
Executive - Regulatory Publishing
TEVA PHARMACEUTICALS INDIA PRIVATE LIMITED
06.2015 - 06.2016
Regulatory Publishing Trainee; Associate - II
NOVO NORDISK GLOBAL SERVICE CENTRE
11.2013 - 05.2015
Master of Pharmacy - Drug Regulatory Affairs
Manipal University
Bachelor of Pharmacy -
Vaagdevi Pharmacy College
Intermediate (12th class) -
Narendra Co-operative Junior College