Regulatory Affairs Quality Assurance

Nagarjuna Reddy Modugu

Tel: +1-904-***-**** Email: *********@*****.***,

LinkedIn: https://www.linkedin.com/in/nagarjuna-reddy-modugu-a59ab915/

PROFILE SUMMARY

Results-driven Regulatory Affairs professional with 14 years of experience in biopharmaceutical regulatory strategy, submissions, and compliance. Expertise in global regulatory submissions for Biologics, Cell & Gene Therapy, And Biosimilars, ensuring alignment with FDA, EMA, Health Canada, and PIC/S requirements. Adept in managing regulatory filings, health authority interactions, and cross-functional collaboration to drive successful approvals and maintain compliance. Proven track record in quality assurance, supplier qualification, GMP adherence, and regulatory information management.

KEY HIGHLIGHTS AND ACHIEVEMENTS:

Led regulatory strategy and execution for biopharmaceutical molecules, including rDNA products and cell & gene therapy products, across development and commercial stages.

Managed regulatory submissions for new biologics (Toripalimab - China, ARC101 - USA) and Cell & Gene therapy (CART: CD19 & BCMA) for both clinical and non-clinical applications.

Spearheaded global clinical trial applications (CTA, IND, IMPD) for Phase I-IV, including submission of DSURs and annual reports. Familiar with CTIR site for EU submissions.

Prepared briefing books and pre-submission meeting documentation for FDA, EMA, Health Canada, and MHRA, facilitating seamless regulatory interactions.

Collaborated with cross-functional teams (Clinical, Non-Clinical, Quality) to align regulatory submission timelines and ensure compliance with global requirements.

Spearheading clinical trial applications CTA, IND & IMPD for Phase-I, III & IV and submission of DSURs & annual reports with the current CT status.

Experience in handling of IND submission to FDA by collaborating with Parexel team. Filling the requirements of Form 1571 and preparation of eCTD content, validation through Veeva RIMS.

Experience in handling CTIS portal with submitter role for submission of CTA to Member State Concerned (EU). Ensured CTIS structured format is followed and validated before submission to HA.

Experience in Handling IRAS portal for submission of CTA to MHRA, handling RFI’s, amendments (Substantial & Non Substantial) and reporting DSURs, EOT & CTR.

Authored and reviewed CMC sections (Drug Substance & Drug Product) for biopharmaceutical submissions, leveraging expertise in eCTD publishing using LORENZ docuBridge & Veeva Publishing.

Managed agency queries (RFIs & Clarifax) and submitted responses within deadlines to support timely approvals.

Led artwork review and approvals for US, Canada, India, and EU markets, and ensuring compliance with PLR & Product Monograph guidance via Karomi software.

Represented Regulatory Affairs in project meetings, providing critical regulatory insights to cross-functional teams.

Assessed GMP-related change controls and submitted variations (Type-I & II, CB0, CB30, and annual reports).

Implemented a Regulatory Information Management System (RIMS) for biosimilar products, optimizing regulatory processes and compliance tracking.

Established supplier qualification processes to ensure supply chain integrity and compliance with GMP standards.

Managed inspection readiness, CAPA submissions, and quality management systems, ensuring adherence to regulatory expectations.

TECHNICAL FORTE

LORENZ docuBridge (eCTD Filing) Regulatory Information Management System (RIMS) Karomi artworks Quality Management Systems (QMS), including TrackWise and SAP Document Management Software (DocHub) Laboratory Information Management System (LIMS) SharePoint Software Microsoft Office Suite (Word, Excel, PowerPoint) AverQ Audit CAPA Management Software SAP Fiori Module for Change Management Computer System Validation (CSV) for 21 CFR Part 11 Compliance Enterprise Resource Planning (ERP) Software

AREAS OF EXPERTISE

Regulatory Filings and Approvals Post-Approval Commitments Management Artwork Review and Submission Project Management in Regulatory Affairs CMC Dossier Preparation and Review eCTD Filing Submission of Variations Packages Preparation and Submission of CTA, IND, IMPD Dossiers MAA Submission Requirements Knowledge GMP Certificates Renewal Tracking Regulatory Information Management Systems (RIMS) Implementation Regulatory Audits Handling Compliance Monitoring Quality Assurance and Control Change Control Management Supplier Quality Audits Incident Management and CAPA Risk Assessment and Management Annual Product Quality Review Documentation Management Training and Development in cGMP Practices Quality Management Systems (QMS) Utilization Computer System Validation Aseptic Practices SAP & ERP Systems Proficiency LIMS and SharePoint Software Use

PROFESSIONAL EXPERIENCE

1.Lead, Regulatory Affairs Cloud Teskis LLC, US Jan-2025

2.Lead, Regulatory Affairs Dr. Reddy’s Biologics Dec-2015 to Jan-2025

3.Executive, QA Audit & Compliance Pfizer (Hospira Healthcare India Pvt Ltd.) Jun-2013 to Dec-2015

4.Executive, Quality Control (MAbs & Insulin formulations) Biocon Biopharmaceuticals Limited Jan-2010 to Jun-2013

KEY DELIVERABLES AT DR. REDDY’S BIOLOGICS:

Regulatory Affairs

Expertise in handling of development stage and commercial stage biopharmaceutical molecules (rDNA products and Cell & Gene therapy products).

Expertise in planning of regulatory submission strategy, plans and tracking deliverables for on time filings.

Managed projects with contract organizations for submission of filings for new biologics molecule (Toripalimab-China and ARC101-USA), Cell & Gene therapy products (CART:CD19 & BCMA) for both clinical and non-clinical submissions.

Spearheading clinical trial applications CTA, IND & IMPD for Phase-I, III & IV and submission of DSURs, PSURs & annual reports.

Expertise in preparation of briefing books and managed interactions with health authorities i.e. FDA & EU for pre submission meetings.

Preparation of documentation for Pre submission meeting requests to FDA, Health Canada & EU & MHRA.

Collaborated with internal team, Clinical, Non Clinical, Quality, commercial & artwork team for aligning submission timelines.

Spearheading clinical trial applications CTA, IND & IMPD for Phase-I, III & IV and submission of DSURs & annual reports with the current CT status.

Experience in handling of IND submission to FDA by collaborating with Parexel team. Filling the requirements of Form 1571 and preparation of eCTD content, validation through Veeva RIMS.

Experience in handling CTIS portal with submitter role for submission of CTA to Member State Concerned (EU). Ensured CTIS structured format is followed and validated before submission to HA.

Experience in Handling IRAS portal for submission of CTA to MHRA, handling RFI’s, amendments (Substantial & Non Substantial) and reporting DSURs, EOT & CTR.

Managed global regulatory submissions BLA (US FDA), NDS (Health Canada), MAA (EU, SA & India) submissions, showcasing audit readiness and compliance excellence.

Expertise in authoring and reviewing CMC sections (Drug Substance & Drug Product) for biopharmaceutical products, proficient in eCTD filings using LORENZ docuBridge.

Drafting the response to the agency queries (RFIs & Clarifax) and submitting the response within the due period.

Expertise in reviewing of country specific artworks including Vial Labels, Carton label & PIL/SmPC for US, Canada, India, & EU. Assisted artwork team for preparation of draft labels for submissions. Handled artwork review and approvals in Karomi software application. Well versed with PLR & Product monograph guidance.

Representing RA for project meetings and providing inputs for Regulatory submission deliverables with cross functional teams.

Compiled the final documents for regulatory submission and ensured reviewed by cross functional teams i.e. QC, R&D, Non Clinical & Clinical team.

Assessed change controls related to GMP and submitted variations (Type-I & II and CB0, CB30 & Annual reports).

Skilled in maintaining compliance with GMP certificates and tracking of post approval commitments.

Pioneered the implementation of a Regulatory Information Management System (RIMS) for biosimilar products

Enhanced regulatory module design and operational efficiency; versatile in managing quality assurance aspects

Quality Assurance-Previous role

Quality Management Systems:

oExpertise in management of Change Controls: Assessment, Approval, Tracking & Implementation of the change including verification of implantation effectiveness check.

oExpertise in Track wise tool for management of deviations, change controls, CAPA, Audit observation modules.

oAssessment of changes impacting on the regulatory submissions and identifying the change types i.e. notifiable change for obtaining approvals or annual notifications.

oHosted Change Control Review Board Meetings (CCRB) for assessment and approvals of Major Change Controls.

oExpertise in handling investigations using FMEA analysis, Ishikawa diagram, cause and effect analysis and identifying the ideal CAPA for addressing the deviations.

oLead the Quality Management Review meetings: Slide deck preparation and tracking of MoM & action closures.

oImplemented Quality module DocHub (D2) in collaboration with open text team.

oSupported out-of-specification investigations, managed market complaint investigations, and maintained quality documentation.

oLead the Quality Management Review meetings: Slide deck preparation and tracking of MoM & action closures.

oReview of APQR reports for Drug Substance and Drug Products and tracking of the action plans from the APQRs.

oManaged market complaints, field alerts and recalls.

oExpertise in preparation of quality risk assessments with respect to the process, facility & quality systems.

Manufacturing Compliance:

oExperienced with QA over sight on third party manufacturing sites of drug substance & drug products for both clinical batches and commercial batches.

oEnsured lot release as per the specifications and country requirements.

oReview & closure of the Change controls, Deviations, CAPA & effective ness checks pertaining to the batch release.

oReview and approve of the protocols & reports related to process validation, cleaning validation, hold time studies and media fill studies.

oSupporting for the review of the batch data for regulatory filings.

oReview of the APQRs and tracking of compliance.

oReview of the batch records and supporting raw data i.e. equipment audit trails, autoclave run records data, batch execution data from MES.

oReview of aseptic practices of the employees periodically and ensure the batches are executed aseptically.

oReview of the media fill data and gowning qualification requirements for aseptic mfg. processes.

Handling of Inspections:

oHosted Regulatory inspections (FDA, EMA, MHRA, Russia, Ukraine, Tunisia, etc.) and drafted the responses to the observations and submitted on time to authorities.

oEnsured to submit the CAPA response along with necessary supporting documents as per the stipulated timelines for various regulatory authorities.

oManaged audit hosting team includes front room, war room, scribes, runner, document controller.

oAuditing experience with manufacturing sites Cell and Gene therapy (CART: CD19 & BCMA), Biopharma (rDNA), Formulations (Small Molecules). Certified Lead auditor in Dr. Reddy’s Biologics.

oHandled Self Inspections at site, prepared risk based self-inspection schedule with FDA 6 system model approach. Qualified lead auditor at site and guiding new qualified auditors on the assessment of systems approach.

oTracking of the Self Inspection CAPAs and their closure.

oExpertise in performing the FDA 483 gap assessment with site systems and drawing of conclusions and tracking for compliance closures.

oLead the gap assessment on FDA 21 CFR Part 11, EU Annexure 1, PIC/s and identified the gaps and drawn the remediation plan for each system and tracking of the action points for closure.

oLead the Quality Management Review meetings: Slide deck preparation and tracking of MoM & action closures.

oPart of quality improvement initiatives including, GEMBA walks, SOP gap assessment against the regulations, investigation improvements and audit readiness.

oLead the gap assessment of quality procedures including Deviation, CAPA, Change Control, Market Complaints, Recalls, Field Alerts, APQR, QRM, Batch release, New Product Launch, Document Management, Site Master file & Self Inspection procedures.

Supplier Qualification:

oQualification of Suppliers of Raw material, Packing material & Consumable materials.

oConducted several supplier/service provider audits and closure of CAPAs.

oPerformed desktop audits with defined audit checklists for supplier’s /service providers. Played key role in developing the checklist questioners.

oTracking of material complaints from the suppliers.

oHandled SCAR (Suppliers Corrective Action Requests) and follow up for closures on time.

oReviewing and signing of the quality agreements with Suppliers and service providers. Negotiating on the quality agreements with suppliers and tracking of the quality agreement due dates for renewal.

oPerforming risk assessments of the material vendors and annual assessments.

oTracking the status of the suppliers in Track wise and scheduling audits.

oEstablished and streamlined a supplier qualification process, ensuring supply chain integrity and compliance with materials and services

oAdept in inspection handling, CAPA submissions, supplier qualification, and quality management systems.

Digital projects-Quality & Regulatory:

oValidated enterprise systems including DocHub, SAP, and RIMS in compliance with 21 CFR Part 11 requirements, executing comprehensive validation lifecycle documentation (URS, DQ, IQ, OQ, PQ).

oSuccessfully implemented Veeva Vault RIMS and Veeva Quality Docs & eQMS modules, enabling streamlined management of regulatory registrations, submissions, and quality processes.

oLed cross-functional collaboration with vendors, CSV, and IT teams to integrate Veeva Quality modules covering Quality Events, Change Management, CAPA, Investigations, Audits, and Training workflows.

oSpearheaded digital transformation initiatives leveraging AI, automation, and digital tools to enhance regulatory and quality operations, improving efficiency and compliance.

oApplied AI and machine learning to regulatory intelligence for automated compliance monitoring, submission preparation, intelligent content summarization, data extraction, and risk-based document review.

oPartnered with KPMG India to automate regulatory dossier generation using AI/ML, leading end-to-end activities including design, requirement gathering, validation, testing, and production deployment.

oLed the implementation of customized RIMS tools (e.g., Harmony RIMS) for biopharmaceutical regulatory management, ensuring global compliance and operational efficiency.

oEnhanced RIMS capabilities to align with IDMP standards, incorporating additional data fields and ensuring regulatory readiness.

oDelivered WWMA report generation within RIMS, enabling full compliance with EMA reporting requirements for product registration and maintenance.

Training:

oDelivered annual cGMP training, and auditor training, and developed training materials focused on aseptic practices and investigation methodologies.

oQualified trainer in aseptic practices and cGMP and lead the training managements in LMS, Created job codes in LMS and implemented training modules for aseptic process.

oPublished weekly dashboard on the overdue trainings. Facilitated annual GMP training sessions.

KEY DELIVERABLES AT Pfizer (Hospira Healthcare India Pvt Ltd).

Worked in Quality assurance team and here are some top skills attained during the tenure in Pfizer India.

oHandled regulatory inspections (like US FDA, EU, Russia, Belarus, Invima, Ukraine & Turkey MOH Audits).

oSelf-Inspections: FDA 6 system based inspection model was followed and risk based self-inspection plan was prepared and executed.

oManagement Review Meetings-Preparation of slide deck and recording of MoM and tracking of actions derived from Management Review Meetings.

oSupplier Qualification: Performed audits of Suppliers audits (Raw material/packing material/consumable material). Executed quality agreements with suppliers and handled material complaints.

oRisk Assessment: Prepared risk assessment in line with ICH guidelines.

oChange Controls: Assessed the changes related product & process initiated from the corporate office (Pfizer-Lake forest) and identified impacting documents for the sites. Played a change champion role.

oInvestigation lead: Participated in the major investigations and trained on KT tools. Assigning of the appropriate CAPAs from the root cause analysis and tracking of the CAPA for closure and implementation with effectiveness check.

oMarket complaints: Handled product market complaints and investigated with involvement of cross functional teams.

oProduct Recalls: Initiated mock recalls and product recalls (Voluntary class-II) recalls.

oAPQR: Preparation of Annual Product Quality Review in line with PIC/S guidelines.

oFDA 483 gap assessment and closure of gaps.

oReview of SOPs and harmonization of the site SOPs in line with corporate.

KEY DELIVERABLES AT BIOCON BIOPHARMACEUTICALS:

oRoutine inspections of Shop floor and Line clearance.

oConducted internal audits in quality department.

oReviewing of QA SOPs for the compliance.

oHandling of Change controls, Deviations, OOS &OOT

oUpdating of FP & RM specifications in ERP for different pharmacopeias (IP, EP & USP)

oPlayed a key role in development of employee training SOP.

oConducted training on different quality documents by PPT

oCompilation of documents required for RA dossier submissions.

oAdherence to c GMP and c GLP and Regulatory requirements.

Validation and Qualification of Instruments:

o Performed the instruments validation/revalidation (temperature mapping)

oPrepared URS, DQ, IQ, OQ & PQ documents for equipment qualification and coordination with venders to get installation and qualification of new instruments

oPreparation of Calibration/Validation/AMC/PM planner for the instruments.

oIssuance and updating the instrument codes for the quality department.

oPlayed a key role in preparation of instrument/equipment qualification SOP

Wet lab work experience:

oTrained on below techniques on cell cultures in Biocon.

Development of cell lines:

oResponsible to Maintaining the cell lines like CHO, SKBr3 & HUT 78 cells and Sub culturing & Trypsinisation of the cells

oPerforming cell count & viability by trypan blue dye exclusion method

oVial thawing and inoculum development in shake flasks

oAnalysis of glucose, lactate & osmolality

oPreparation of cell banks like MCB & WCB

oResponsible for monitoring of liquid nitrogen levels in cryocans which contains cell bank cryo vials.

Biological assay validation:

oPerformed cell based assays like cell proliferation & complement mediated assays.

oHandled flow cytometry and detection of biological activity of particular biosimilar drug by single point and detection of potency by parallel line assay.

oResponsible for preparation of the protocols and reports of particular method

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