MITHUN N M
Bengaluru
Summary
Lead Business Analyst with 13+ years of experience in regulatory affairs and eCTD publishing, specializing in translating business needs into scalable technology solutions within highly regulated environments. Extensive experience across global regulatory frameworks including USFDA, Health Canada, TGA, and ASEAN, with strong expertise in requirements gathering, stakeholder management, and solution design.
Proven track record in conducting workshops, driving requirement elicitation, and collaborating with IT teams to deliver innovative solutions, including AI-assisted authoring initiatives. Strong background in Quality Management Systems (QMS), document management platforms (Veeva Vault, EPIC), and end-to-end regulatory submission lifecycle management. Recognized as a Subject Matter Expert (SME) for leading teams, mentoring associates, and implementing process improvements that enhance quality, compliance, and operational efficiency.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Lead II - Business Analysis
US Technologies India Private Ltd.
Bengaluru, India
10.2025 - Current
- Prepared and reviewed regulatory documents ensuring accuracy, completeness, and compliance with applicable guidelines
- Conducted and participated in workshops to gather requirements and align documentation with stakeholder expectations
- Presented regulatory documents, workflows, and updates to internal teams and stakeholders
- Acted as Subject Matter Expert (SME) and coordinated with the IT team to support development of an AI-assisted authoring solution
- Collaborated with cross-functional teams to gather inputs and ensure timely document preparation and delivery
- Managed and guided team members in document preparation, quality checks, and adherence to standards
- Performed quality checks to identify inconsistencies and ensure high-quality, compliant deliverables
Subject Matter Expert
Celegence Systems Pvt Ltd
India
12.2021 - 03.2024
- Supported the end-to-end publishing of INDs, NDAs, MAAs in eCTD format for biosimilars and medicinal products and ANDAs for generics.
- Formulated and implemented submission strategies based on regional regulatory frameworks (EU, US, APAC, and other international markets like Thailand, Japan), working cross-functionally to assemble high-quality packages.
- Created and formatted documents according to eCTD specifications, adhering to both client and regulatory standards.
- Performed rigorous quality control checks to ensure submissions met ICH guidelines and client-defined compliance standards.
- Contributed to Quality Management System (QMS) initiatives, including documentation control and audit readiness.
- Managed and maintained the Regulatory Submission Tracker for all Life Cycle Management (LCM) activities across global markets, ensuring visibility and compliance with submission timelines.
- Led LCM activities, including regulatory variations, renewals, PSURs, DSURs, RMPs, and responses to health authority queries.
- Designed and developed document templates to meet client-specific regulatory submission requirements.
- Conducted CAPA management and gap analysis activities to support regulatory process improvements and compliance remediation.
- Contributed to special initiatives and process optimization projects, enhancing regulatory efficiency and compliance.
- Delivered comprehensive Veeva Vault (DMS) support, including document versioning, lifecycle management, and workflow coordination.
- Mentored team members and delivered training on regulatory guidelines and publishing tools.
- Resolved technical and procedural issues related to document preparation, publishing, and regulatory submissions.
- Served as the regulatory liaison with global affiliates and stakeholders to ensure timely and accurate submissions across markets.
- Provided input for KPI tracking and performance analysis, supporting strategic insights on submission timelines and approval metrics.
Regulatory Operations II
MMS Holdings Inc.
Bangalore
09.2016 - 12.2021
- Prepared and compiled regulatory submission documents for health authorities across global markets.
- Managed end-to-end publishing and dispatch of INDs, NDAs, for biosimilars and combination medicinal products in eCTD format (US region) and ANDAs for generics, CMC Variations.
- Ensured submissions adhered to ICH eCTD standards, including the creation of bookmarks, hyperlinks, and submission-ready formatting.
- Conducted thorough quality control checks to ensure submissions complied with ICH guidelines and organizational standards.
- Referenced applicable regulations and guidance documents (ICH, FDA, EMA) for accurate daily submission preparation.
- Formatted documents using client-specific authoring templates and performed redactions for public disclosure forms.
- Served as internal auditor for ISO 9001:2008, supporting quality audits and documentation standards.
- Performed quality checks of TLGs (Tables, Listings, Graphs), Define.xml vs Specifications, and Define.pdf vs Define.xml for SAS datasets.
- Conducted abbreviation and consistency checks for clinical and regulatory documents.
- Actively supported regulatory operations using Veeva Vault RIM for a named client—mentoring associates in creating and managing applications, registrations, and regulatory objectives.
Senior Process Associate
Tata Consultancy Services
Pune Area, India
08.2014 - 09.2016
- Publishing Activities (Template Creation, Word Document Formatting, Creating Bookmarks and Hyperlinking using Plug-ins, Smartdesk and ISI Toolbox, Smartdesk for Authoring)
- Componential Publishing and Word formatting for Various Protocols, PSUR, IB SAP, Literature References, IMPD, CMC documents, Method validation reports, DSUR, EU-RMP
- Publishing of various submissions for EU region
- Process Improvements in PDF as well as in Word doc has been implemented in Team: Pre-optimization method, Literature Reference Extraction and Hyperlinking, Symbols formatting, Figures Rendition
- Cleared Lean Six Sigma Green Belt on Symbols formatting in CMC Documents and Reference Extraction
- Creation of Applications, and Registrations using Veeva Vault RIM.
- Performing Quality control checks to ensure the high quality of submission
- Adobe Acrobat troubleshooting regarding errors in Optimization, Pre-flight methods.
Junior Regulatory Associate
LIQUENT, a PAREXEL Company
Bangalore
10.2012 - 08.2014
- Pre-publishing of regulatory documents which includes, applying regulatory guidelines and specifications to make them regulatory compliant.
- Worked on template conversion and word document formatting using Authoring Tools.
- Publishing of various INDs, NDAs, ANDAs, MAAs for US, EU Validating submissions using different validation tools.
- Worked on data migration from GREaT and ORION to Insight Manager.
- ECTD, NeeS and Paper publishing & Validation, Lifecycle Management and Document Processing & Formatting.
- Publishing activities using Insight Publishing, Smartdesk, ISI toolbox Insight Manager for Registrations.
Education
Mastery of Pharmacy - Pharmacy, Pharmacognosy
Government College of Pharmacy
Bengaluru, India01-2011
Bachelor's of Pharmacy - Pharmacy
SCS College of Pharmacy
Harapanahalli01-2007
Skills
- Customer Focus
- Training and mentoring
- Strong analytical skills
- Project Planning
- Decision-Making
- Problem-solving aptitude
- Multitasking
- Effective Communication
Certification
- Lean Six Sigma Green Belt (ICGB)
- Internal audit ISO 9001:2008
LANGUAGES
English
Kannada
Hindi
WEBSITES, PORTFOLIOS, PROFILES
www.linkedin.com/in/mithunnm-35068314
Timeline
Lead II - Business Analysis
US Technologies India Private Ltd.
10.2025 - Current
Subject Matter Expert
Celegence Systems Pvt Ltd
12.2021 - 03.2024
Regulatory Operations II
MMS Holdings Inc.
09.2016 - 12.2021
Senior Process Associate
Tata Consultancy Services
08.2014 - 09.2016
Junior Regulatory Associate
LIQUENT, a PAREXEL Company
10.2012 - 08.2014
Mastery of Pharmacy - Pharmacy, Pharmacognosy
Government College of Pharmacy
Bachelor's of Pharmacy - Pharmacy
SCS College of Pharmacy