Anudeep B H

• Got recognized and Promoted from Junior Regulatory affairs associate to Regulatory Affairs Associate.
• Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.

• Experienced in publishing standards for different regions. Involved

in end to end publishing activities.

• Knowledge in publishing activities like Bookmarking, Hyperlinking. Experienced in peer QC of processed and submission ready document. Publishing of eCTD, paper, NeeS, FSA, eDOK and SPL OC submissions to various regulatory agencies i.e.,US, EU, UK, Australia, Switzerland, Canada and Eurasian region
• Experienced in Submission of published sequences through different gateways in accordance to the specific regions i.e., CESP, EMA, Web trader, MHRA etc.,
• Enhanced working relationships by participating in team-building activities.
• Handled customer concerns and escalated major issues to supervisor. Involvement in client communications.
• Fixing of validation issues after publishing the package.
• Experience in tools like Insight Publisher, Ennov, SmartDesk, Lorenz Validator and EURS validator and Veeva Vault.
• Helped create, implement and adopt best practices on internal processes and procedures.
• Acted as key compliance contact, answering queries promptly and politely.

• Gathered, evaluated, organized, managed and collated information in varying formats.
• Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
• Worked with governance committees to make and evaluate plans.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
• Prioritized project-related tasks to efficiently complete essential tasks.
• Prepared and maintained document inventory for core dossier preparation.
• Handling initial marketing authorization application (MAA), baseline submissions for EU and post approval activities like annual reports and amendments, variations - Type II, 1A, 1AIN,1B (National, DCP and MRP), response (supplemental information), answer to HA questions. (Responses to HA), PBRER/PSUR (EU).
• Publishing of Periodic Safety Reports, pharmacovigilance reports such as PADER, PBRER.
• Involved directly in client communications also troubleshooting of validation issues.
• Preparation of slides on various topics and training the team on the same.
• Experience in tools like Extedo, ISI Toolbox, Lorenz Validator and EURS validator and Veeva Vault.
• Knowledge of publishing standards for US-FDA, EMA, EUROPEAN , EA-EU and GCC regions
• Knowledge on publishing activities like Bookmarking, Hyperlinking and compilation of Module 1 to Module 5 files.
• Involvement in QC of processed and submission ready documents.

• Publishing of eCTD, paper output/dossiers and NeeS submissions to various regulatory agencies, handling of DCP, MRP, CP and National submissions.

• Maximized customer engagement and satisfaction by delivering excellent customer service.
• problem-solving skills.

• Communication skills.

• Problem-solving.

• Team/Peer Management.

• Troubleshooting.

• Built and maintained courteous and effective working relationships.

• Consistency in presenting the data and publishing (eCTD conversion) CTD Modules.
• Responsible for end-to-end publishing activities and timely deliverables. Assisted regulatory support with the publishing, compilation and validation of electronic based regulatory documents including Annual Reports, DSUR, PSUR, PBRER, RMPs, Clinical Protocols, Protocol Amendments, Statistical Analysis Plan, MAP, IB addendums Safety Reports, Responses to agencies, Drug Discovery, Quality Summary Documents.
• Peer Reviewing different types of document like Clinical Study Reports (CSR), Investigator Brochures.
• Creating internal and external links using the pdf tools in the published output with ISI Tool box.
• Document-level publishing to make documents submission ready as per the submission standards (e.g., bookmarking, linking, PDF version, etc.) Understanding of industry standards related to eCTD, and other variations of electronic submissions and document publishing and uploading and downloading dossier into CARA.
• Provide quality and timely deliverables to meet the client's expectation.
• Utilized desktop publisher software to examine printed materials and verify design elements remained intact.
• Interacted with authors to define job requirements and resolve content and scheduling issues.
• Worked within multilevel approval structures to maintain quality standards for work.
• Formatted in Microsoft Word and PDF to prepare documents and proposals for review or final submission.