JUHI DUBEY
Regulatory Affairs Professional
Mumbai,Maharashtra
Summary
Regulatory Affairs Professional with more than 9 years well spent on learning several submission types and filing processes across US, CA, EU and ROW markets. A quick and keen learner, always looking further to hone my management and technical skills for self-improvement and organizational growth
Overview
10
10
years of professional experience
5
5
years of post-secondary education
Work History
Hub Submission Manager
Pfizer India Pvt. LTD
Mumbai, Maharashtra
01.2024 - Current
- TA Lead for India Region
- Responsible for a Managing Team of 8-10 colleagues including vendors.
- Responsible for planning, monitoring and delivering the submissions to meet the business objectives.
- Cross-functional collaborations to drive regulatory submissions across India Region.
- Ensuring alignment with business and regulatory Goals.
- Responsible for conducting KOM with stakeholders involved, executing E2E submission.
Senior Associate (Hub Submission Manager)
Pfizer India Pvt.LTD
01.2022 - Current
- SPOC (RCM+HSM) – Accelerated Portfolio (COVID Vaccine &
- Oral) Markets – TH, VN, ID, PH, US (IND), Swiss and India Cluster
Regulatory Change Manager
12.2019 - 12.2021
- RCM) - Global; Single Point of Contact (SPOC) - US
- Submissions (NDA, ANDA)
- Currently working as a Regulatory Change Manager (RCM) and Submissions
- Manager (SM) for US, Swiss, India Cluster and APAC markets for the accelerated portfolio (lightspeed) submissions related to active COVID-19 therapies and molecules
- Supporting labeling, lifecycle and other major submissions inclusive of paper , eSub and eCTD formats
- Worked as a Single Point of Contact (SPOC) by handling Hub Submissions
- Manager (HSM) and Regulatory Change Manager (RCM) responsibilities for various products in US market
- Responsible and accountable for planning, management and delivery of eCTD and electronic submissions to US-FDA and Health Canada
- Prepare regulatory documentation as per ICH standards and make them submission ready for different markets across the globe
- Perform initial and post publishing regulatory review of documents included in a submission package
- Review of regulatory submissions including NDA and INDs – Rosetta
- Phoenix
- Validating the published outputs – Lorenz e-validator
- Coordinating and interacting with other departments of the organization to discuss and provide solutions to various regulatory issues – Labeling, CMC
- Strategy, Country Experts
- Lending support to in-country regulatory strategy in query resolution, lifecycle management queries and document publishing/formatting related queries
Business Process Lead
Tata Consultancy Services
06.2015 - 12.2019
Sr Process Associate
TCS
12.2015 - 01.2019
- VX, RIM , CMC
- Working as a trainer for CMC compliance process
- Responsible forCMC(Chemistry, Manufacturing and Control) Variatione-CTD
- Module 3related to creation and updates related to electronic dossiers (e -
- CTD Module 3) to be submitted to regulatory authorities and assisting in
- CMC work- creation of Sequences/Assemblies and/or any remediation associated with the same
- Have experience in Liquent Insight Manager
- Maintain complete understanding of Regulatory Information
- Management, Product Lifecycle Maintenance and activity specific guidance documents
- Performing internal QC activities and supporting archival of documentation
- Regulatory interact and co-ordinate with project manager/regional affiliate to ensure accuracy and completeness of data in system
- Remediation of product application and registration details in Regulatory information management system for pharmaceutical, medical devices and consumer healthcare products
- Support the Global Regulatory Affairs team and LOC’s
- Responsible for accurately remediating the existing legacy data, adding new entries and deleting entities within the system (if applicable) so that it is an authoritative source of product registration information which is readily available to the other key processes in GSK
- Ensure Quality and TAT targets are achieved
- Also to perform activities such as Creating and updating Applications, Events
- Creating PDS’s (for new Applications)Updating PDS for existing Applications
- Creating and updating Registrations
- Active participation in regular interaction with Central regulatory, Clients and
- LOC’s for Data Requirement
- Attend trainings pertaining to OPAL and Regulatory process
- Archiving documents in electronic repository.
Education
Master of Science - Microbiology
SXavier's College
Mumbai 06.2013 - 05.2015
Bachelor of Science - Microbiology
Kishenchand Chellaram College
Mumbai 06.2010 - 04.2013
Skills
- Regulatory Submission Management
- PCO Communication
- Dossier Coordination/Compilation
- Dossier Review
- Publishing Review
- Cross-Team collaboration
- Liquent Insight Manager
- Liquent Publisher
- Rosetta Phoenix
- Lorenz e-Validator
- FDA ESG Web Trader
- Litera Software
Strategic planning
Team leadership
Project management
Cross-functional teamwork
Key performance indicators
Employee onboarding
Recognitions
- Successfully completed the FUEL programme (Future Women leadership development programme) conducted by Pfizer. Awarded certificate post 9 months of training
- Service Awards for 5 years of Excellence.
- Certificate of Recognition for demonstrating Excellence and exceptional Team work.
- Multiple BRAVO awards for showing excellence while delivering submission.
- Recognized by Pfizer many times for contributing to the success of the team in Pfizer Town Hall.
- Awarded for Functional Excellence by GSK-TCS.
- Certification of Appreciation for contribution to Team's achievement - GSK-TCS
- Certificate of Performance Recognition for dedication, ownership and drive for Result by GCK-TCS
Tools Handled
- Liquent Insight Manager
- Track Wise (Submission Planning Application)
- Product Dossier Manager (PDM)
- Liquent Publisher
- Rosetta Phoenix
- Lorenz e-Validator
- FDA ESG Web Trader
- Global Document Management System
- Litera Software (IMPD submissions)
Timeline
Hub Submission Manager
Pfizer India Pvt. LTD
01.2024 - Current
Senior Associate (Hub Submission Manager)
Pfizer India Pvt.LTD
01.2022 - Current
Regulatory Change Manager
12.2019 - 12.2021
Sr Process Associate
TCS
12.2015 - 01.2019
Business Process Lead
Tata Consultancy Services
06.2015 - 12.2019
Master of Science - Microbiology
SXavier's College
06.2013 - 05.2015
Bachelor of Science - Microbiology
Kishenchand Chellaram College
06.2010 - 04.2013
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