Mithun NM
Bengaluru
Summary
Subject Matter Expert specializing in regulatory affairs, with a strong track record of managing eCTD Publishing and Submission activities for major regulatory authorities, including EU, USFDA, MHRA, Health Canada, Swiss Medic, TGA, GCC. Skilled in data migrations, quality management systems (QMS), document management systems (DMS), customer relationship management, product demonstrations, requirement gathering, escalation handling, and post-implementation client support. Committed to ensuring regulatory compliance in all aspects of operations. Veteran Subject Matter Expert with 11 years of experience in Publishing and Submissions. Experienced in developing and implementing training programs and standard operating procedures as well as advising and reporting to executives for continued progress in productivity.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Subject Matter Expert
Celegence
India
12.2021 - 03.2024
- Assisting Publishers in INDs, NDAs, ANDAs, MAAs for US in eCTD format for Biosimilar's and Medicinal Products and Gateway submission
- Compilation of documents for submission to regulatory health authorities for US, Thailand and Japan
- Request Proposal Support for various RIMS and Publishing Projects
- Document Preparation as per eCTD format
- Veeva Vault (DMS) support
- Quality control checks to ensure compliance with ICH and Client defined standards
- Quality Management System support
- Developing Templates as per the client standards
- CAPA Management
- Troubleshooting in the Document Preparation and Submissions.
Regulatory Operations II
MMS Holdings Inc.
Bangalore
09.2016 - 01.2022
- Preparing and compiling documents for submission to regulatory health authorities
- Publishing & Submission of various INDs, NDAs, ANDAs, MAAs for US in eCTD format for Biosimilar's and Medicinal Products (Combinations) and dispatching
- Publishing & Submission for EU region and dispatching
- Publishing regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards by creating bookmarks, hypertext links, etc
- Using eCTD publishing tools and document management systems
- Performing quality control checks to regulatory submissions to ensure compliance with ICH and company defined standards
- Referencing applicable regulations and ICH guidance documents to complete daily work
- Word document formatting using client Authoring Templates
- Redaction for Public Disclosure Form
- Involved as internal auditor and audited as per ISO 9001:2008
- QC of TLGs (Tables, Listings and Graphs), Define.xml Vs Specification and Define.pdf Vs Define.xml for SAS
- Abbreviations checks for the Clinical Documents
- Publishing activities using - Docubridge, Insight Publishing, Smartdesk, ISI toolbox Insight Manager for Registrations, Rosette e-validator
Senior Process Associate
Tata Consultancy Services
Pune Area
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
- 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
Master's degree in Pharmacy - Pharmacognosy
Government College of Pharmacy
01.2011
Bachelor's degree in pharmacy - Pharmacy
SCS college of Pharmacy
01.2007
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)
Languages
- English
- Hindi
- Kannada
Publications
- Antibiotic Potential Activities of the Chloroform, Methanol and Water Extracts of Tinospora cordifolia Plant
- Eclipta alba(L.) A review on its Phytochemical and Pharmacological Profile
- Antimicrobial Activities of the Petroleum Ether, Chloroform, Methanol and Water Extracts of Eclipta alba L
- Isolation and Characterization of Triterpenoid Glycoside from the Whole Plant of Eclipta alba L
Timeline
Subject Matter Expert
Celegence
12.2021 - 03.2024
Regulatory Operations II
MMS Holdings Inc.
09.2016 - 01.2022
Senior Process Associate
Tata Consultancy Services
08.2014 - 09.2016
Junior Regulatory Associate
LIQUENT, a PAREXEL Company
10.2012 - 08.2014
Master's degree in Pharmacy - Pharmacognosy
Government College of Pharmacy
Bachelor's degree in pharmacy - Pharmacy
SCS college of Pharmacy
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