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Regulatory affairs specialist

Location:
Morrisville, NC
Posted:
October 22, 2018

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Resume:

Soumya Pippiri

ac7giu@r.postjobfree.com

919-***-****

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



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