Sanjay Choudhary

Regulatory Submissions Management:
• Responsible for preparation of M1 documents, review, and submission ASMF and EDQM submissions of EU variations (Nat, MRP/DCP) for a portfolio of approved products to the European Medicines Agency (EMA) and national competent authorities (NCAs) across the EU member states
• Involved in kick-off meetings for the new Biosimilars submissions, Agenda settings, Stakeholders role, Submission timelines and Milestones with stringent timelines execution and submission of dossiers for Biosimilar products to HA
• Responsible for end quality check of submissions before it will be submitted to HA along with Quality check for M1 documents prepared by peers.
• Working flexibly and balancing multiple priorities to meet company goals and complete the tasks with high quality.
Strategic Guidance & Stakeholder Coordination
• Good negotiation skills includes Active Listening, Effective Communication, Assertiveness and good at Managing Conflict
• Involved in multiple small project management activities for MAA transfers and Baselines
• Regularly communicating with cross functional teams for timely processing of variations and HAQ- responses for small molecules
• As a part of my role, I deliver comprehensive training sessions to new joiners
Regulatory Compliance & Requirements
• Ensure the capture of high-quality regulatory data.
• Identify and communicate data errors and inconsistencies, and drive data remediation initiatives as required.
• Manage the delivery of compliance reports required to support business stakeholders.
Process Improvement & Innovation
• Contributed in Veeva implementation testing as a super user in process improvement team.
• Worked closely with regulatory teams to streamline publishing workflows.
• Troubleshoot issues related to document uploads, metadata tagging, and system performance.
• Collaborate with cross-functional teams to ensure smooth submission execution.

• Review, compile, and publish US regulatory submissions, including Promotional, Safety, Annual Reports, Initial Submissions, and Amendments in eCTD format.
• Manage LATAM submissions in NeeS format.
• Publish critical documents such as CSR,CRF,SPL and Datasets for the US.
• Efficiently resolve errors identified by the Lorenz Validator.
• Collaborate with Submission Managers to plan and execute partial submission tasks.
• Oversee the archival process for regulatory submissions into the Veeva repository.
• Ensure timely execution of tasks with high quality and compliance to regulatory guidelines, utilizing checklists as required.
• Conduct knowledge transfer sessions for new hires.

• Handling various submissions like eCTD and NEES
• Worked on submissions for US, AU, EU-CP and NeeS
• Publishing of major and critical submissions like CSR and Datasets for US along with Major Biological submissions for US
• Good at handling the errors thrown by the Lorenz Validator
• Hands on experience in Document publishing for Hyperlinking and Bookmarking of the documents using ISI toolbox
• Well versed with SRS of the document