Reading, Travelling, Dancing
Hi, I’m
Tripti Rastogi
Regulatory Submission Lead
Bangalore
Summary
Focused on driving personal and organizational development in dynamic settings, emphasizing teamwork and a passion for lifelong learning.
Overview
16
years of professional experience
1
Certification
1
Language
Work History
GSK India Global Services Private Ltd
Regulatory Submission Lead, Submission Delivery Excellence, LCM
09.2019 - Current
Job overview
- Responsible for end-to-end delivery of assigned complex lifecycle regulatory submissions (Renewals, Site Registration, Tenders, HAQs, MAT Transfer, Variations) ensuring they meet agency requirements, agreed dossier strategies and timelines while proactively managing risks and remediation.
- To prepare strategy, effective planning and drive the execution of the agreed plans to ensure submission is on-track to deliver per agreed Global Regulatory Strategy & coordinate with stakeholders (LOC, SC, PO, Non Clinical & Clinical), liaising with (Global Manufacturing Sites, External Supply QA, Third party sites, supply chain & cross functional teams) in order to meet project timelines as per strategic milestones.
- Leading drafting, authoring and technical review of complex, multi-market dossiers to deliver high-quality, compliant submissions that adhere to GSK standards and regulatory guidance.
- Providing subject-matter expertise to lead and mentor the team, enhancing capabilities in regulatory strategy, QC review of the submission packages and help team to resolve queries, for excellent authoring, and consistent adherence to SOPs and Work Instructions.
- Develop and sustain collaborative cross-functional relationships with internal and external GSK stakeholders like manufacturing sites, regulatory authorities or third-party service providers to coordinate submission deliverables, address concern, resolve issues and implement fit-for-purpose regulatory strategies.
- Was part of Process Improvement Initiative to develop templates within Veeva for Various Submissions with seamless collaboration with Country Affiliates & cross functionals project teams. Updating REQUIRE and other regulatory databases on a regular basis for changing requirements.
- Supporting LOCs for implementation of approved documents for commercial supplies.
- Understanding regulations, guidelines, procedures and policies relating to registration, local laws, manufacturing and drug development of various pharmaceutical products, R&D processes and objectives and participation in Regulatory execution meetings to expedite the submission alongwith approval process.
- SPOC for external GMS sites for monitoring progress of projects, liaising with ESQ and driving constructive meetings with site, resolving queries to ensure timely deliverables.
- Mentoring of new joiners, Submission Coordination colleagues, and coaching team members within India, Cairo & Mexico centers, providing guidance on GSK WOW, tools & systems for different kind of submissions.
- Functional trainer for new joiners and providing Job shadowing session and other trainings as and when required.
- Tools & Systems used: Veeva Vault, Power BI, RASCAL, IMMS, OPAL, REQUIRE, LOCATE, CMAC, COGNOS, INTEGRIFY
- Regulatory Associate Manager- II from Oct 2021 to April 2023
- Senior Regulatory Specialist from Sep 2019 to Oct 2021
Sun Pharmaceutical Industries Ltd
Manager II- Corporate Regulatory Affairs
12.2014 - 09.2019
Job overview
- Responsible for registration of pharmaceutical products for various regulatory submissions (New filings, Variations, Annual reports, dossier extension).
- Ensure project initiation for PE/CDP study till completion of PE study & on completion of BE study, timely dossier filing in Brazil to meet project timelines.
- Strategize Regulatory Submission plan, Compilation and review of dossier in line with expectation of country regulatory authorities & submission with minimum lead time.
- PHC filing (Post approval changes) as per guidance requirements. Review of APR & all change controls to ensure submission of all changes in anniversary period of product.
- Interpreting agency guidelines and review of Analytical Validation reports & validation protocols. Reviewing various technical documents including the Dissolution Development report, Product development report, Product Spec/STP, Stability data, BMR,BPR ,change controls, MFC, MPC, Dossier extension form for line extension of dossiers etc.
- Support in product launch on getting approval and Life cycle management for the product for continuous supply for approved products.
- To co-ordinate with all cross functional department like R&D for various drug development phases, Business development, manufacturing site, CQA, Project management, marketing and Packaging development, supply chain with regular meetings to keep track of various activities for timely submission.
- Imparted training on various locations (R&D, Plants) for validation requirements & new guidelines & to resolve their queries for accuracy of regulatory documents preparation.
- Knowledge about various regulatory guidelines, and worked on formats CTD, ACTD, ZA-CTD, e-CTD, GOOSE Artwork Management system, LIMS.
- Worked on regulatory softwares like Pharma-Ready, EURS-Validator.
- Dosage forms worked: Solid Orals, Injectables, Lyophilized formulations, Liquid orals.
- Reported to GM-Regulatory Affairs
- Sr. Executive Corporate Reg Affairs from Dec 2014 to Jun 2016
- Managed and motivated employees to be productive and engaged in work.
Alembic Pharmaceuticals Ltd
Sr. Executive -Regulatory Affairs
06.2012 - 12.2014
Job overview
- Responsible for registration of products for BRAZIL, Africa & other ROW markets.
- Ensure project initiation from samples dispatch till completion of PE study & on completion of BE study for Brazil market, timely dossier filing to meet project timelines.
- Compilation and review of registration dossiers in line with expectation of country regulatory authorities & required formats (CTD, Country specific).
- Preparing dossiers for Online review/audit by customers and handling respective queries.
- Dealing with R & D, Plant site, Corporate QA, International Business Team, Project Management Team, supply chain and updating status & progress of projects and managing submission documents.
- Knowledge of DMS – Document Management System for various documents like BMR’s, BPR’s, Specifications and STP’s.
- Customers Handled: Amgen, Sandoz, Adcock Ingram, Aspen, Teva, Sanofi
- Executive- Regulatory Affairs from June 2012 to May 2014
Simpex Pharma Pvt. Ltd.(A part of ZAO CORAL-MED Russia)
Regulatory Affairs Executive
01.2010 - 05.2012
Job overview
- Responsible for timely preparation of good quality dossier with regulatory compliance with respect to country requirement and CTD format for Russia, CIS Region.
- Reviewing various technical documents including Product Specs &STP, Stability protocols & data, Batch manufacturing, & Packing records etc regular coordination with site and R&D.
- Ensuring Regulatory compliance after regulatory approval to make hassle free commercial supplies as per regulatory commitment of individual countries.
Education
Govt. college of Pharmacy, Amravati University
M.Pharm from Pharmacognosy & Phytochemistry
01.2009
University Overview
- (M.S.)
- GPA: 67.6%
Dr. K.N. Modi Institute of Pharmaceutical Education & Research ModinagarU.P.
B. Pharm
01.2005
University Overview
- Affiliated to UPTU, Lucknow (U.P.)
- GPA: 69.01%
Skills
Optimistic perspective People-oriented approach Friendly demeanor
team-oriented collaboration
Open-minded approach
concurrent functions
Effective communication skills
Organizational skills
References
References shall be provided on request.
REWARDS AND RECOGNITION
- Received 17 Bronze awards till date for managing various complex submissions and projects.
- Received 3 Silver awards for managing multiple challenging renewals/projects.
- Country Champion for Caricam Region in Year 2020., Country Champion for ROW Markets for Renewal Veeva Vault Template Management in Year 2024 and received Bronze award too. Appreciation as best Mentor in year 2024 for training members across centers (India, Mexico, Cairo).
- Awarded cash prize for the project "Development and Evaluation of Novel Anti-inflammatory Herbal Formulation" in a workshop organized by Unijules life sciences., Qualified (GATE-2006) conducted by IIT Kharagpur with 92.01 percentile and received MHRD scholarship for research in M.Pharm by AICTE.
- Awarded “SAF Madanjeet Singh Scholarship” on behalf of UNESCO by “Jamia Hamdard University”,New Delhi., College Topper in M.Pharm & 4 Publications in different journals of repute.
Development Program
- Completed GCC Capabilities of future – “Project Management Capability program” and received Certificate in year 2024.
- Completed GCC Capabilities of future-“Working in Matrix organization program” received Certificate in year 2024.
Disclaimer
I declare that the particulars given in this resume are true to the best of my knowledge and belief. Date: 02/12/2025 Place: Bangalore
ADDITIONAL QUALIFICATION
- Post Graduate Diploma in “Drug Regulatory Affairs” from Jamia Hamdard University, New Delhi. [Year-2007, 65.67%]
- Industry Diploma in “Contract Research and Clinical Trials” from Bioinformatics Institute of India, Noida. [Year-2006, 68.99%]
PERSONAL PROFILE
- Nationality : Indian
- Strength : Possess good orating and effective communication skills to agree prioritization, self-confidence, decision making
- A meditator and Art of living Teacher and want to spread vibes of positivity and happiness and making this world a happy place for everyone.
Interests
Certification
DEI Champion Certification
Timeline
DEI Champion Certification
12-2023
Regulatory Submission Lead, Submission Delivery Excellence, LCM
GSK India Global Services Private Ltd
09.2019 - Current
Manager II- Corporate Regulatory Affairs
Sun Pharmaceutical Industries Ltd
12.2014 - 09.2019
Sr. Executive -Regulatory Affairs
Alembic Pharmaceuticals Ltd
06.2012 - 12.2014
Regulatory Affairs Executive
Simpex Pharma Pvt. Ltd.(A part of ZAO CORAL-MED Russia)
01.2010 - 05.2012
Govt. college of Pharmacy, Amravati University
M.Pharm from Pharmacognosy & Phytochemistry
Dr. K.N. Modi Institute of Pharmaceutical Education & Research Modinagar
B. Pharm