Bhumika Yakkanti

Global Regulatory Strategy & Execution-

• Spearheaded the development and execution of global regulatory strategies for pharmaceutical and medical device products, ensuring compliance with FDA, EMA, TGA, PMDA, and Health Canada regulations.
• Collaborated cross-functionally with CMC, quality, clinical, and manufacturing teams to align submission timelines with regulatory requirements.

Regulatory Submissions Management-

• Led original submissions (INDs, NDAs, sNDAs, NDSs, CTAs, MAAs) for US, Canada, and EU, including kick-off meetings in partnership with the Regulatory Strategist. Conducted kick-off and submission tracking meetings and prepared meeting minutes.
• Organized and participated in submission team meetings with GRS, ensuring alignment with contributors and partners while overseeing the submission content plan from Module 2 to Module 5.
• Owned and maintained the dynamic Submission Project Plan, tracking dependencies for each module and dispatch date.
• Developed submission project plans using wTOC for submission tracking meetings.
• Reviewed submission content plans, timelines, and critical path documents with the team.
• Provided guidance to publishers on compiling content, publishing submission dossiers, and preparing final dispatches for Health Authorities.
• Performed final technical quality review and provided sign-off for dispatching submissions.

Publishing & Submission Validation-

• Performed electronic submission publishing, validation, and dispatch using industry-standard eCTD publishing tools.
• Ensured compliance with FDA eCTD, NeeS, and PDF formatting requirements, including hyperlinking, bookmarking, and metadata optimization.
• Identified and resolved document formatting and publishing issues in collaboration with relevant teams.
• Conducted final quality control (QC) checks on formatted documents and published outputs before submission to Health Authorities.

Regulatory Document Authoring & Review-

• Reviewed submission documents for Module 2 as per the submission content plan.
• Participated in Technical Quality Review for Modules 1-5, ensuring high-quality, on-time dispatch to Health Authorities.
• Coordinated content-related team and management reviews, ensuring close collaboration with the Regulatory Strategist.

Regulatory Operations & Workflow Optimization-

• Developed and maintained checklists, content tracking logs, and submission planning tools to optimize regulatory workflows.
• Continuously assessed and improved submission processes to enhance turnaround time and compliance.
• Communicated critical updates and changes during tracking team meetings, identified action items, and escalated issues when timelines were at risk of delay.

Regulatory Information Management (RIM) & System Expertise-

• Managed regulatory document workflows in Veeva Vault RIM, Veeva Submission Workbench, and Lorenz Docubridge, ensuring real-time tracking, archival, and compliance.
• Performed post-submission processing activities such as acknowledging submission receipt from authorities, capturing metadata in RIMS, and communicating submission receipt to key stakeholders.

Training & Regulatory Standards Development-

• Conducted training sessions for the team on various types of submissions and the publishing process.
• Developed and maintained standardized submission SOPs and style guides to ensure consistency across regulatory teams.
• Led comprehensive training on eCTD publishing best practices, submission templates, and global regulatory requirements.

Regulatory Intelligence & Health Authority Engagement-

• Maintained proactive engagement with FDA, EMA, Health Canada, and other health authorities.
• Participated in regulatory meetings, provided clarification on agency feedback, and tracked commitments and correspondences in Veeva RIM.

Technical Troubleshooting & Submission Issue Resolution-

• Identified and resolved eCTD publishing issues, validation errors, and regulatory submission failures.
• Provided technical guidance on submission imports, lifecycle management, and compliance reporting to ensure smooth regulatory operations.

Cross-Functional Collaboration & Global Coordination-

• Worked closely with preclinical, clinical, CMC, manufacturing, and quality teams, as well as external regulatory consultants, to streamline submission preparation, review, and dispatch.

Regulatory Submissions & Compliance-

• Published regulatory submissions for U.S. FDA and Health Canada in compliance with health authority guidelines and industry best practices.
• Managed life cycle management submissions, including U.S. Promotional Labeling and Advertisement submissions.
• Ensured the quality, content, and format of submissions fully complied with FDA regulations and guidelines.

Submission Planning & Quality Control-

• Planned, prepared, performed quality control (QC), and submitted regulatory submissions to health authorities in various formats, including eCTD and eCopy, ensuring timely delivery.
• Ensured all assigned submissions underwent proper QC review, and all QC findings were effectively addressed.
• Prepared submission documents in accordance with agency guidance and the style guide to meet regulatory requirements.

Cross-Functional Collaboration-

• Collaborated with cross-functional teams to align submission timelines and ensure timely document deliverables for submission publishing.
• Participated in the development and maintenance of Regulatory Operations systems, processes, checklists, and procedures to maintain consistency.

Publishing & Document Management-

• Provided component-level publishing support for Regulatory-owned deliverables in PDF format, ensuring all dossier components conformed to submission standards (e.g., bookmarking, linking, PDF version control, etc.).
• Reviewed Word and PDF-based documents to ensure compliance with the company’s publishing requirements and document standards.
• Performed PDF rendering using Adobe and worked with ISI Toolbox to assign hyperlinks, bookmarks, and batch operations.
• Compiled and prepared documents, ensuring all modules were ready for publishing and cloning for U.S. life cycle management of existing products.

Technical Troubleshooting & Process Improvement-

• Tracked technical errors and implemented improvements to ensure higher-quality submissions with minimal rejections from health authorities.
• Demonstrated expert knowledge of eCTD submission requirements and life cycle management concepts for eCTD submissions.
• Created FDA accounts for ESG submission and managed other Regulatory Operations systems.

Regulatory Operations & System Management-

• Independently formatted, published, transmitted, and archived various submission types while overseeing the development and maintenance of processes, templates, and style guides to ensure high-quality published content.

Document Preparation & Publishing-

• Formatted, edited, reviewed, and generated publish-ready PDFs of submission documents in accordance with standardized templates and the Regulatory Style Guide.
• Gained experience in document-level publishing using Adobe and Adobe plugin tools, ensuring compliance with FDA’s regulatory requirements.

Regulatory Monitoring & Updates-

• Monitored the Orange Book and other FDA databases for updates to labeling and patent/exclusivity information that may affect potential or pending ANDA products.

FDA Form & Query Preparation-

• Prepared FDA forms with detailed facility information for drug substance/drug product manufacturing facilities and outside testing facilities/laboratories for the ANDAs and various queries.
• Reviewed and electronically maintained change request forms (CRFs) for all products.

Document Submission Preparation-

• Reviewed CBE/CBE-30/PAS documents before submission.
• Prepared cover letters, 356h forms, and all ANDA-related forms.

eCTD Compilation & Publishing-

• Prepared and compiled drug substance and drug product information into eCTD format; bioequivalence summary tables, demonstrating knowledge of electronic publishing (eCTD) requirements.
• Reviewed and drafted Module 3 (CMC) of eCTD submissions.
• Prepared and compiled drug substance (Module 3.2.S) and drug product (Module 3.2.P) into eCTD format; bioequivalence summary tables (Module 2.7), ensuring compliance with eCTD publishing requirements.

Reports & Labeling-

• Prepared Annual Reports and Periodic Adverse Drug Experience Reports (PADERs).
• Reviewed and approved package inserts and labeling, updating them in line with RLD/RS labels.

Collaboration & Tracking-

• Interfaced collaboratively with internal and external partners for management of submissions.
• Tracked committed timelines and proactively followed up with internal departments for required documents.

Pharmacovigilance

Adverse Event Management-

• Handled pharmaco-vigilance activities and prepared ADE responses.
• Prepared Periodic Adverse Event Drug Experience Reports.
• Handled Product Quality Complaints (PQC’s) and Adverse Drug Events (ADE’s).
• Actively followed up with patients/reporter/physician for follow-up questions, batch details, and seeking consent from patients to reach the physician.

Safety & Quality Follow-Up-

• Actively followed up with the safety team and quality team to ensure investigation completion from a safety and quality standpoint.

Reconciliation & Complaint Handling-

• Performed reconciliation activities of adverse events and product complaints.
• Handled product inquiries, such as gluten-free status, country of manufacture, carbohydrate content, etc.

Regulatory Review & Reporting-

• Provided regulatory reviews of customer complaints, ADEs, and defined the regulatory reportability.
• Prepared ADE Update Summary for all third-party products.

Regulatory Submission Management

ANDA Submission Compilation & Review-

• Compiled and reviewed documents for ANDA submissions, ensuring that regulatory submissions were adequate and error-free, with minimal open issues.

Submission Tracking & Communication-

• Communicated with affiliates to track submissions and the submission status, ensuring alignment across teams.
• Responsible for data entry, filing, compliance, archiving, and maintenance of the submission tracking database.

Data Management & Reporting-

• Managed and processed data using Excel spreadsheets, ensuring accuracy and timely updates.
• Delivered on-demand reports to meet internal business needs and regulatory authority requirements, tracking registration activities and status.

Regulatory File Maintenance-

• Provided support to the regulatory department to ensure proper organization and maintenance of regulatory files for tracking and archiving of regulated documents.

ANDA & Amendments Coordination-

• Coordinated with supervisors in the preparation of ANDAs, Amendments, and managed PADERs (Periodic Adverse Drug Experience Reports).

eCTD Compilation & Submission-

• Compiled, reviewed, published, and submitted dossiers in eCTD format, in compliance with regulatory guidelines.