Harsh Vardhan C. Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

• US C.I. Reporting – Monitoring news related to generics & biosimilar business with respect to US market on topics like approvals, product launch, pipeline progression, business development, M&A, government landscape, drug pricing, bills passed, FDA news, patents & litigations, recalls, shortages, warning letters, 340B program, PBMs and government affairs• Conference and Investor Relations Calls coverage – Tracking & providing insights on competitors & customer companies• Biosimilars overview and Reporting – Update of information on competitors – Update of commercial deals (global licenses agreements, commercial partner, and developer status), stage of development, data readouts of pivotal studies, filing, approval & launch status• Specific Product monitoring – Gathering intel on specific brands & products for US commercial interest • Ad-hoc - Patent expiry and litigation monitoring for brands of interestSkills: CI news alerts, Conference coverage, Company and product profiling, Secondary research, Pipeline analysis, Competitive launch timelines, Data mining and summarization, Drug pricing and reimbursementData Sources - Citeline - Generics bulletin, IPD Analytics, Evaluate, Analysource, FirstWord Pharma, Fierce Pharma, DrugsStore News, 340B newsroom, Biosimilars forum, clinicaltrials.gov, Company websites and other publicly available sources

Hyderabad, Telangana, India

● Support regulatory teams during the submission process in all administrative and technical steps according to global procedures● Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements ● Ensure eCTD lifecycle maintenance according to ICH and regional specifications● Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant● Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates● Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents● Ensure escalation procedures are followed in case of issues and delays● Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness● Might be involved in document bulk upload activities

India

● Accountable for preparation, validation, and submission of compliant and high-quality initial, second wave, and maintenance regulatory filings from a global perspective; and dispatches to all the European Competent Health Authorities● Direct communication with European Competent Health authorities on expediting approval timelines, ensuring regulatory compliance, coordinating responses to Health Authority Queries, and tracking associated response● Leading the transition project for regulatory publishing from Europe to India; involved designing the training plan and material for the successful onboarding of 6 associates and creating a checklist for ensuring quality submissions● Preparation and review for completeness and correctness of Module 1 administrative documents like the cover letter, electronic application form, annexures like GMP certificate, manufacturing license, flowcharts, and Qualified Person declarations● Provide operational expertise to the team for routine maintenance submissions to ensure the timely, quality preparation and execution of electronic submissions to Global Health Authorities while supporting process optimization and facilitating updates of working practices● Cross-functional liaison between managers, medical department, labeling department, country organization, and health authority to ensure efficient global collaboration and successfully obtain regulatory approvals from European Health authorities in the defined timeline● Optimization of regulatory compliance activities, including entering product-specific attributes into the compliance database; investigating deviations and escalations, coordinating self-inspections and audits, providing inputs as subject matter expert, reviewing SOPs, identifying data integrity issues, and implementing the CAPA● Support timely update of submission data in the regulatory information management databases and accountable for the data compliance

Novartis Hyderabad

- Manage the club’s account, write checks as approved by the executive committee, and deposit membership dues payments and other club revenues- In charge of submitting membership dues payments to World Headquarters (accompanied by the names of renewing members)- Filing necessary tax documents, and keeping timely, accurate, up-to-date financial records for the club

Master Of Science - Ms, Pharmacology And Toxicology

Bachelor Of Pharmacy - Bpharm, Pharmacy, First

Biology, General, First