Nikhilesh Rath
Manager, Regulatory Affairs
Bangalore,KA
Summary
Forward-thinking Operations Specialist bringing 12+ years of expertise in Regulatory Operations, RIMS (XEVMPD), Medical Devices, People Managements. Cultivates rapport with individuals to optimize project goals and output, resolve complex problems and deliver innovative improvement strategies. Proficient in Veeva RIM and eCTD/ eCTD publishing tools.
Overview
2025
2025
years of professional experience
Work History
Manager, Submission Publishing
Genpact, Bangalore, India
6 2021 - Current
- Handling eCTD dossier building and compiling which includes life cycle management (expedited sequences, same day safety submission, annual reports, protocol amendments, OPDP submissions, PADER, Information amendment, CMC amendment, labeling supplement, withdrawal request, activation and reactivation status, cross IND and NDA etc.) and original submission
- Leading the Canada Submission end-to-end process
- Handling the NEES submission with Validation of the submission build for various regulatory bodies using Lorenz validator
- Client facing role which includes direct interactions and working on submission plan and negotiating on timelines, resolving the queries, retrieving the files from FTP, archiving and zipping and making ready to submit through ESG
- Quality review (pre and post validation backbone check) of eCTD making them submission ready for FDA, EMA submissions
- Aware about Compilation of Module 1 to 5 dossier for eCTD/Nees Submission
- Ensure that specific project specifications or standards, if they exist, are strictly adhered to throughout the lifecycle of the submission
- Conduct issue resolution, communicating with the onshore/client to ensure that all issues are resolved in a compliant manner
- Have given various innovative ideas that have made the process efficient
- Project coordination and team management
Variation Specialist
Baxter India Private Limited
04.2019 - 06.2021
- Coordination of Assessments (Drug and Devices) by RA Change Control Central Team
- Documentation of each individual country assessment in the RA assessment grid
- Standard change control tasks by country for a reportable change
- Coordination and tracking of deliverables by RA Change Control Central Team
- Coordinate with Global Regulatory Lead to complete the Deliverable Tracker, assist in delivery compilation and Notify the GRL when RA tasks are closed
- Preparation of submission packages for variations as per regional guidelines
- Review and provide regulatory documentation for submission of registration changes to global Health Authorities
- Responsible for working with other parts of the regulatory organization to achieve desired results
- Ensure identified standards and content requirements are met for regulatory submissions
- Timely, actively support query responses
- Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
- Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s)
- Maintain regulatory files in a format consistent with requirements
- Tracking of status, quality/compliance and progress of regulatory documentation
- Review, edit and proofread regulatory documentation
- Involved in Preparation of Workflows, Procedures and trackers as per CCM Process
- Assisting new members on CCM Process and help them to Onboard
- Product Life cycle Management: Substance product registration Information, Product Dictionary Management, Submission Planning and tracking, Document and Submission Management, Product Registration, DMF Tracker, Change Management Tracking Approval and rejection
- Touchpoints: Manufacturing Change Control, Product Supply release market, Clinical Operation (1572s, IB, IMPD, CTA)
Document Processing Sr. Analyst
Accenture Services Private Limited
08.2013 - 04.2019
- Senior submission coordinator, process analyst and subject matter expert (XML compiling and publishing) for Accenture – eCTD Publishing of documents (Module 1 to Module 5) which includes Reports such as Batch Manufacturing Records, Labeling, Drug Safety Reports, Non Clinical and Clinical Study Reports, Investigator Brochures, Protocol, Six monthly safety report, Annual Safety report, Nees and making it compliant for submissions to US-FDA and EMEA
- Working on around 15-20 clients on a daily basis
- ECTD dossier building and compiling which includes life cycle management (expedited sequences, same day safety submission, annual reports, protocol amendments, OPDP submissions, PADER, Information amendment, CMC amendment, labeling supplement, withdrawal request, activation and reactivation status, cross IND and NDA etc.) and original sequences
- Validations of the submissions build for various regulatory bodies using Lorenz validator
- Client facing role which includes direct interactions and working on submission plan and negotiating on timelines, resolving the queries, retrieving the files from FTP, archiving and zipping and making ready to submit through ESG
- Quality review (pre and post validation backbone check) of eCTD making them submission ready for FDA, EMA submissions
- Well aware about Compilation of Module 1 to 5 dossier for eCTD/Nees Submission
- Ensure that specific project specifications or standards, if they exist, are strictly adhered to throughout the lifecycle of the submission
- Conduct issue resolution, communicating with the onshore/client to ensure that all issues are resolved in a compliant manner
- Have given various innovative ideas that have made the process efficient
- Project coordination and team management
- Driving Operational Excellence within Team
- Preparation of Quality Reports
- Mentoring and Grooming Individuals
- Preparing compliance tracker
- Leading the Knowledge sharing team
Education
Master of Science - Pharmaceutics
School of Pharmaceutical Sciences
Bhubaneswar 04.2001 -
Bachelor of Science -
School of Pharmaceutical Sciences
Bhubaneswar 04.2001 -
Skills
Life-cycle management (eCTD/ NeeS)
Submission Gateways: ESG
Medical Devices Co-ordinator
(ISO 13485 and EU MDR
regulations)
Expert in RIM Vault,
eCTDXpress, Lorenz
Docubridge , EXTEDO
eCTDmanager, Lorenz
eValidator
Teamwork and Collaboration
Process Improvement
Time Management
Data Analysis - Tableau &
Excel
Project Management
Excellent Communication
Continuous Improvement
Multitasking
Self-Motivation
Accomplishments
Managed a team and improvised the quality of work for a
new team.
Used Microsoft Excel to develop dashboard for
management to monitored and controlled quality and
team utilization.
Completed various original US ANDA and GCC
submissions prior due date and dispatched.
Honored with
1. Awarded NumeroUno Associate in team Accenture – 2015
2. Have been declared as the Most Promising Associate & Project Coordinator within Regulatory Operations for Turn Around of High Priority Deliverables within Tight Timeliness
3. 1. Awarded Client Champion Award. in Accenture – 2014 & 2015
4. Awarded Star Business Excellence - Baxter
5.Hero of the month - Genpact
6. Silver award - -Genpact-2023 and 2024
Timeline
Variation Specialist
Baxter India Private Limited
04.2019 - 06.2021
Document Processing Sr. Analyst
Accenture Services Private Limited
08.2013 - 04.2019
Master of Science - Pharmaceutics
School of Pharmaceutical Sciences
04.2001 -
Bachelor of Science -
School of Pharmaceutical Sciences
04.2001 -
Manager, Submission Publishing
Genpact, Bangalore, India
6 2021 - Current
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