SWAPNA BAPATLA

Responsibilities

• Manage EMEA Regulatory operations, evaluate workloads every quarter and secure necessary resources to support Business KPIs.
• Provide guidance to cross-functional teams from Regulatory Information Systems, Operations, and Publishing perspective.
• Build strong working relationships with Global and Regional Regulatory Leads including 3rd Party Regulatory and distribution partners from the regions.
• Oversee and support Business initiatives aimed at improving internal Regulatory standards and systems such as document control systems, Publishing Systems, and Product Registration databases and/or Global Regulatory Information Management System (Veeva).
• Conduct periodic analysis of existing Business Processes to identify opportunities for continuous improvements and to ensure industry standards and expectations are met.
• Evaluate new Veeva functionality for feasibility and impact on the Business.
• Assist with internal and external audits when notified by Regulatory agencies, offering advice to the Safety department on improvements with any system related outcomes.
• Project Lead Veeva, other RIMS systems implementation, content management, and process improvement.
• Manage, inspire, and motivate both EMEA and Global Regulatory Operations teams, supporting their personal and professional development.
• Monitor the performance of EMEA Regulatory operations team, setting objectives to the individuals by interpreting the Business priorities, conduct performance reviews twice a year, provide feedback, and advise on performance improvements.
• Lead and manage day-to-day Regulatory operational activities including planning, tracking, resourcing, publishing, internal reviews, submitting, and archiving activities in the EU, EEA, and ME regions.
• Support Regulatory Strategy and deliver high-quality Regulatory Submissions across the regions for submissions such as MAAs, Baseline, Line extensions, Lifecycle management activities such as Post-approval Quality, Labelling & Safety variations, and aggregate reports.
• Successfully Project manage the initial phase of ISO IDMP impact and gap assessment and oversee Regulatory contributions as part of the IDMP program, continuing to progress into IDMP implementation phase (DADI/PMS).
• Support Safety department with PSMF publishing and update performance reports in Annex F and product licensing information in Annex H.
• Brought to in-house and successfully managed all xEVMPD activities for Business, continuing to provide expert advice on any questions received from EMA Article 57 team.
• Proactively identify, engage, and support migration activities where Regulatory systems are impacted.
• Lead cross-functional teams for the migration and integration programs for Veeva RIMS, EDMS, and Publishing tools.
• Strategise and execute data extraction, data clean-up, data mapping for over 500K documents and 6k submissions and perform UATs for the new Regulatory systems.
• Provide Subject Matter expertise in exploration and selection of vendors and IT Systems in accordance with the Business requirements.
• Review and analyse configuration releases of Veeva and publishing tools in a timely manner.

Responsibilities

• Manage day-to-day Regulatory operational activities including planning, tracking, publishing, peer review, submitting, and archiving activities in the EMEA region.
• Support Regulatory Strategy and deliver high-quality Regulatory Submissions across the regions for submissions such as Baseline, Line extensions, Lifecycle management activities such as Post-approval Quality, Labelling & Safety variations, and aggregate reports.
• Successfully managed all xEVMPD activities and respondence to questions received from Article 57 QC team.

Responsibilities

• Oversee the progress of data migration projects from Documentum and Liquent Insight to CARA and Veeva RIMS.
• Identify the formulation codes for food supplements and medications and connect intricate source data structures to target structures in the RIMS.
• Offer technical expertise regarding data process flow.

Responsibilities

• Collaborate with stakeholders to obtain required documentation for the MA transfer project.
• Assist in the creation of project implementation steps and documentation, such as M1 and M3 documents.
• Compile and distribute the final package to G&L Scientific for submission through the CESP portal.
• Regularly provide status reports on the project's progress every two weeks.

Responsibilities

• Identify core packages redaction requirements for emerging markets based on the Regulatory requirements
• Amend and delete the intellectual and in-depth details of Module 3 Dossier and Quality Overall Summary from the EU, US and Canada dossier.

Responsibilities

• Led the project for the Global Regulatory Operations team and maintained excellent communication with cross-functional teams within RB.
• Prepared the initial data collection for the pilot phase, identified data sources, and conducted workshops within cross-functional departments. Also, kept track of the guidelines released for IDMP implementation process.
• Conducted cross-functional team meetings and workshops to resolve unidentified data sources and business processes for IDMP projects.
• Worked closely with the Regulatory Operations Systems team and Business Analyst to identify the core data fields for IDMP implementation.
• Provided extensive support in identifying the vendor system for IDMP implementation.
• Identified issues in existing systems and provided suggestions for further improvement of Regulatory Information Management systems.
• Utilised the following databases: EDMS (Lotus Notes), Documentum, GRAIS (Aris Global - Regulatory Information Tracking system), Aris-Global IDMP tool.

Responsibilities

As the lead trainer for Global Regulatory Information Tracking and Reporting systems, it is my responsibility to ensure the effective incorporation of Liquent Insight, Documentum, Publishing, and other Regulatory in-house databases. This includes liaising with the development team and external vendors, providing training and technical support to cross-functional teams, and acting as the business administrator for RIMS, Documentum, and other Regulatory Databases.

Other key responsibilities include the following:

• Upgrading, hotfixing, and performing validation checks on publishing tools and Regulatory Information Management System
• Supporting the execution of validation scripts, preparation of SOPs and user guides for Global Regulatory systems
• Ensuring document components are submission ready and compliant with Regulatory requirements
• Assisting the Global Regulatory team in preparing, publishing, and submitting published dossiers and PSURs
• Submitting PSRs through PSUR repository
• Ensuring xEVMPD data is updated in accordance with Article 57(3) guidance and the data is audit ready
• Leading the IDMP implementation project within Consumer Healthcare, including data collation, conducting workshops within cross-functional departments, and staying up-to-date with the latest IDMP user guidelines and implementation process requirements.

Responsibilities

• Performed gap analysis on registered dossiers as part of the Compliance Project, offering high-quality support to both Regulatory and Quality teams.
• Managed product renewals, registrations, variations, and site change documents to EMEA.
• Provided superior Regulatory services to UK, Ireland, and International divisions within Seven Seas, as well as third-party distributors in designated international markets through ongoing communication and liaison.
• Collaborated with country affiliates to understand dossier requirements and offer appropriate support.
• Published dossiers (NeeS and Paper) and delivered submissions within agreed timelines.
• Aided the Global Regulatory Information Management team in developing and implementing the new Regulatory Information Tracking System based on Liquent Insight.
• Effectively tracked and traced the status of all submissions.
• Assisted external consultants by providing critical documents to progress in Site Transfer Project.
• Developed training materials and provided training to external consultants and colleagues within Seven Seas UK Regulatory.
• Worked collaboratively with all cross-functional teams, mainly including R&D, QA, and Supply.
• Monitored product registration status for all consumer products across all markets.
• Contacted health authorities and PAGB where required to ensure product information is current in their database.
• Reviewed artworks against labeling guidelines and processed approval in Zen.
• Monitored cross-functional changes that affect Regulatory dossiers.
• Assisted the Drug Safety team in providing Regulatory information to update Product Safety Update Reports.

Responsibilities

• Acted as the main point of contact for all Reckitt Benckiser Health & Personal Care affiliates and external consultants to handle compliance project-related queries.
• Prioritized product inventory lists and assisted in scheduling products to be made compliant.
• Coordinated document translations where necessary and requested CPPs.
• Verified the dossiers compiled by Global RSE colleagues before forwarding them for Gap Analysis.
• Supported Global and Local Regulatory colleagues in dealing with various issues during the compliance project's collation stage.
• Interacted with Global Regulatory, R&D, Supply, Manufacturing, Procurement, Supply and Release to Market teams to resolve any issues related to license expiry or copy license.
• Reviewed registered dossiers and ensured all necessary information is available for consultants to perform gap analysis and remediation activities.
• Executed CMC activities through effective coordination, strategy, and implementation.
• Issued Regulatory submissions, variations, renewals, responses to questions in line with defined CMC Regulatory plans as needed.
• Maintained project implementation plans and variation submission and approvals records.
• Communicated effectively with cross-functional teams.
• Proficient in using complex Regulatory databases.
• Provided support to new employees on internal databases training such as Documentum and SharePoint.

Responsibilities

• Distinguished customer service delivery
• Responded to all inquiries, assisted customers in locating general merchandise and demonstrated product usage
• Provided relevant information and directed clients to the appropriate department
• Offered related sales and services to increase customer awareness of the product range and value
• Ensured that all merchandise was correctly and clearly priced
• Maintained and updated sales displays, provided quotations, and checked product availability
• Arranged merchandise on shelves/aisle end to promote sales and set up promotional displays
• Managed payment transactions, resolved customer complaints, and issued refunds when necessary
• Referred complex problems to management when necessary
• Adhered to company policies and procedures when assisting customers.

Responsibilities

• Uploading critical documents in electronic hierarchy for various phases of Clinical Study
• Conducting Trial Master File audits to ensure compliance with standard operating procedures and guidelines
• Reporting any missing content or inappropriate data into Pfizer systems
• Performing peer review for reports generated by other vendors and producing secondary reports
• Conducting follow-up assessments for unsatisfactory studies
• Ensuring the accuracy of study team reviews and performing reconciliation as required
• Grading work sheets produced by other vendors like Icon, Kendle, PharmaNet and Quintiles
• Utilizing expertise in complex Pfizer databases such as ELARA and Right Track II
• Assisting in the preparation of reports, metrics, and tracking spreadsheets through SharePoint
• Updating SOPs and training materials as required

Responsibilities

• Provided help and support in handling clinical data issues.
• Maintained and supported clinical databases and edit checks.
• Edited check rules and other programs to ensure data validation.
• Loaded, formatted, and transferred data into clinical databases using Oracle.
• Created and maintained a customer support tracking database.
• Supported Microsoft Exchange 2003 Server in a clustered environment, including managing mailbox users and troubleshooting communication issues.
• Installed, configured, and troubleshooted department systems and various peripherals such as scanners, modems, tape backups, printers, SCSI devices, hubs, switches, and projectors.
• Conducted periodic software and OS upgrades/patches for Windows XP, 2000 Server, and Workstation.
• Provided user, helpdesk, and desktop support for Windows 2000/NT, XP, Microsoft Office, and other software.
• Demonstrated proficiency with various operating systems in Microsoft Windows and Linux environments.
• Administered and managed Windows 2000 Server.
• Coordinated technology for conference meetings, including laptops and projectors.
• Installed systems under Windows.
• Provided system support for over 120 employees.