Soumya Pippiri
ac7giu@r.postjobfree.com
SUMMARY
Experienced Regulatory operations professional with expertise in publishing reports and submissions to FDA, EMA and other health agencies. Technical expert in using different publishing tools including Freyr SUBMIT, Docubridge, eCTD Xpress, Liquent Insight, ISIPublisher, ISIToolbox and Lorentz validator
Experienced in development and review of Regulatory Intelligence reports for markets like US, EU, and RoWcountries for Drugs and Medical Devices
Worked on New Drug Applications (CTAs, New NDA/BLA, ANDA), New Investigational New Drug Applications (New IND) and Drug Master Files (DMF) in Electronic CTD (eCTD) to FDA
Authoring and create Dossier content from source documentation as needed for registrations and provide writing support for technical reports
Assisted in the review and approval of documentation to be included with regulatory filings, including labeling content, CMC documents, Non-clinical documents, Clinical documents and other associated marketing documentation
Experienced in development and review of Regulatory update reports, Marketing authorization requirement reports (Annual reports, Safety reports) for drugs
Assisted in collecting and coordinate information for regulatory documentation packages for CTD submission from different departments of Clients and vendors
Performed analysis of Regulatory Pathway, Hurdles and interpretation of laws and guidance
Developed a portal (Freyr INSIGHT) ensuring delivery of clinical and regulatory intelligence information to partners at Client location and other colleagues
Experienced in drafting of Non-clinical and Clinical sections i.e., CTD overviews and summaries
Working experience with tools like Regulatory Document Management System (rDMS), Documentum, Trackwise, Freyr SUBMIT and Freyr INSIGHT
Assisted in the development of local product label documents (such as Core Data sheets, SmPC, USPI, SPL and PIL) and associated Local Language documents for USA and EU countries
Experienced in leading product specific regulatory meetings and cross functional submission teams meeting to oversee, plan and deliver regulatory filings, responses to regulatory queries, and preparation of regulatory meeting materials
Assisted RA Manager in preparing and compiling Module 1 (Administrative Information) and Module 3 (CMC information) for ANDA application
Working knowledge of ICH, GMP& GDP guidelines and sound knowledge about drug development process
PROFESSIONAL EXPERIENCE
Johnson & Johnson Vision Care, Morrisville, NC March 2018 – Present
Regulatory Affairs Specialist
As part of a project team, involved in preparing regulatory submissions (USA and International markets) for new products and modifications to existing products to ensure timely approval for market release
Evaluating change orders for regulatory impact and providing strategies
Involved in Review and approval of marketing, advertising and promotional material to be used for USA and International markets
Developing labeling documents for USA and International markets like Instructions for Use, Package Insert and artwork labels for Class I and Class II Medical Devices
Provide guidance, development, and review of product labeling including artwork labels for all the Medical Devices
Involved in labeling activities to initiate and deliver labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials in compliance with global and regional standards and regulations
Reviewing and Updating the labeling documents on a timely basis according to internal SOPs and regulatory requirements of the respective country
Work as a part of cross-functional teams (R&D, Quality, Manufacturing, Marketing, and Finance) to provide regulatory guidance and advice and to identify, evaluate, and mitigate risk.
Developing user and service documentation and training for medical devices and test fixtures (multiple formats, including print and video)
Developing strategies and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations, and labeling stakeholders
Evaluating risks, identifying alternatives or proposing new labeling approaches to resolve critical issues
Freyr Regulatory Services, Princeton, NJ April 2014 – Feb 2018
Sr. Associate - Regulatory Operations
Project Name: Labelling & Regulatory CMC Technical Writing
Client: Glenmark pharmaceuticals
Provided CMC Regulatory support as needed through the authoring, co-authoring or review of CMC sections of the NDA Original Submissions, NDA Supplements, NDA Annual Reports, ANDA submissions, IND Amendments and Annual Reports.
Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports
Collaborated with other cross-functional partners to support compliant execution of change management via the review of CMC-related change documentation.
Assess and communicated potential CMC Regulatory risks to products and/or projects and propose mitigation strategies.
Delivered all CMC Regulatory milestones for assigned products across the product lifecycle.
Ensure all dossiers follow appropriate SOPs and ICH guidance.
Preparing and reviewing labeling documents such as Core Data Sheets (CDS), Summary of product characteristics (SmPC), Patient Information Leaflet (PIL) and United States Package Insert (USPI), Structured Product Labeling (SPL) according to regulations of USA and EU countries
Experienced in development and review of local product label documents (such as Core Data sheets, SmPC, USPI, SPL and PIL) for USA and EU countries according to the labeling regulations
Experienced in drafting of regulatory documents, including Nonclinical and Clinical Overviews & Summaries to support elected submissions for different ICH regions (US & EU)
Involved in review and approval of documentation to be included with regulatory filings, including labeling content, labeling documents and other associated marketing documentation according to US and EU requirements
Developed and reviewed the content of CDS, USPI, SPC and their associated Patient Labeling Documents for NCE, OTC and ANDAs
Involved in tracking and Updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements
Drafted Regional Prescribing Information (RPI), Patient Information leaflet (PIL) documents for Marketing Authorization Application, Variations/Supplements & Renewals
Ensured that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion
Involved in end-to-end auditing of the labeling process to ensure Quality Compliance
Project Name: Regulatory Operations
Client: Johnson and Johnson
Served as a key member of the Regulatory Operations Group and responsible for Dossier submission planning, preparing and submitting Supplements, Amendments and Annuals Reports drugs in eCTD and hybrid format to Health Authorities (FDA & EMA)
Experienced in drafting of regulatory documents, including Nonclinical and Clinical Overviews & Summaries to support elected submissions for different ICH regions (US & EU)
Experienced in drafting and reviewing of protocol documents and clinical trial reports
Developed Regulatory Intelligence and Marketing intelligence reports to cater the client needs for different regulated markets like FDA, EMA, Health Canada and RoW markets
Managed Submission Publishing of New Drug Applications (CTAs, New NDA/BLA, ANDA), New Investigational New Drug Applications (New IND) and Drug Master Files (DMF) in Electronic CTD (eCTD) to FDA, EMA and RoW countries
Report Publishing of Clinical Study Reports, Preclinical Reports, Summary Reports, Annual Reports
Assisted in the development of global regulatory intelligence insights and provided appropriately positioned regular communications to the organization about future and expected changes to the global regulatory environment
Developed a comparative filing requirements document for all the member states in EU region with all the regulatory submission requirements for pharmaceuticals
Performed identification & assessment of emerging regulatory intelligence and updating the stakeholders and clients about its impact
Interacted with Regulatory Program Management Leaders to plan submissions to health authorities/agencies within defined timelines, and in accordance with established company standards and protocols
Performed quality control checks to ensure integrity of eCTD submissions
Project Name: Regulatory Operations
Client: Novartis
Served as a key member of the Regulatory Operations Group and responsible for Dossier submission planning, preparing and submitting Supplements, Amendments and Annuals Reports drugs in eCTD and hybrid format to Health Authorities (FDA & EMA)
Experienced in drafting of regulatory documents, including Nonclinical and Clinical Overviews & Summaries to support elected submissions for different ICH regions (US & EU)
Experienced in drafting and reviewing of protocol documents and clinical trial reports
Developed Regulatory Intelligence and Marketing intelligence reports to cater the client needs for different regulated markets like FDA, EMA, Health Canada and RoW markets
Managed Submission Publishing of New Drug Applications (CTAs, New NDA/BLA, ANDA), New Investigational New Drug Applications (New IND) and Drug Master Files (DMF) in Electronic CTD (eCTD) to FDA, EMA and RoW countries
Report Publishing of Clinical Study Reports, Preclinical Reports, Summary Reports, Annual Reports using the ISI Publisher publishing tool
Experienced in bookmarks and Hyperlinks using VLM tools in ISI Publisher
Assisted in the development of global regulatory intelligence insights and provided appropriately positioned regular communications to the organization about future and expected changes to the global regulatory environment
Developed a comparative filing requirements document for all the member states in EU region with all the regulatory submission requirements for pharmaceuticals
Performed identification & assessment of emerging regulatory intelligence and updating the stakeholders and clients about its impact
Interacted with Regulatory Program Management Leaders to plan submissions to health authorities/agencies within defined timelines, and in accordance with established company standards and protocols
Performed quality control checks to ensure integrity of eCTD submissions
Performed Literature search on recent research articles, review articles and clinical trials data for OTC products and their respective therapeutic areas for drafting Addendums to Clinical overviews and other regulatory documents
Supported the translation of regulatory guidelines in to English, when the information is collected in local language from their respective country regulatory body website
Drafted the Clinical and non-clinical sections of the regulatory documents
Project Name: Regulatory Intelligence Insights
Client: Otsuka Pharmaceuticals
Expertise in using Bookmark and Hyperlink tools in Virtual Link Manager in ISI Publisher
Good understanding of FDA & EMA submission requirements including eCTD formats
Assisted in the preparation of eCTD dossiers for submission to regulatory authorities
Drafted regulatory documents including Nonclinical and Clinical Overviews & Summaries to support eCTD submissions for different ICH regions (US and Europe)
Provided publishing support for assigned projects to ensure high quality paper and electronic dossiers are submitted to health authorities within aggressive deadlines
Maintained high quality for all submission projects without missing timelines
Setting up publications using Report templates, assigning documents and splitting of source documents per planner document
Drafting Clinical sections of documents like PSURs and Overview documents
Prepared and circulated regulatory INSIGHTS related to client product portfolio and market
Development of Posters, Newsletters, presentation slides for webinars and conferences
Risk, benefits assessment for proposed regulatory strategies and offering solutions
Project Name: Teleflex Regulatory Operations
Client: Teleflex
Prepared Literature reports on recent medical device guidelines for global markets for FDA and EMA, and on recent updates related to products of Teleflex
Experienced going through Regulatory authority, government websites and news articles were the search engines considered for drafting
Drafted Insights of medical device guidelines and news articles for Teleflex for US and EU
Dr. Reddy’s Laboratories, Hyderabad, India May 2013 - Mar 2014
Regulatory Affairs Coordinator
Served as a member of the Regulatory Operations Group and assisted for preparing and submitting Supplements, Amendments and Annuals Reports for New Drugs and Investigational drugs in eCTD, paper, and hybrid format to Health Authorities
Helped in developing Quick reference cards for various publishing processes
Performed Quality Check for Reports and Submissions Published by Other Publishers
Developed submission content plans and timelines for major submissions such as original INDs, and NDA major CMC supplements
Performed submission building activities; ensuring submissions are built with submission-ready documents
Supported the creation of inter-document links, ensured quality of the documents were up to the mark and validated compiled submissions
Provided publishing support for assigned projects to ensure high quality paper and electronic dossiers are submitted to health authorities within aggressive deadlines
Maintained high quality for all submission projects without missing timelines
Setting up publications using Report templates, assigning documents and splitting of source documents per planner document
EDUCATION
Master’s degree of Pharmacy, Osmania University, Hyderabad, India (2011-2013)
Bachelor’s degree of Pharmacy, Jawaharlal Nehru Technological University Hyderabad, India (2007-2011)
TECHNICAL PROFICIENCIES
ISI Writer and ISI Toolbox, Docubridge, eCTD Xpress, Liquent Insight, ISI Publisher, SharePoint, TrackWise, Freyr INSIGHT, Freyr SUBMIT, A4L, SPL Xforms, Arena, Bartender and MS Office