Tanweer Ansari

Experience

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  Dabur Reseach Foundation

  May 2004 - Dec 2005

  Research Scientist

  DRA Formulations (US & EU Market), Dabur Research Foundation, Ghaziabad• Provide regulatory in-put for development of generic drug formulations• Compile Technology Transfer Documents• Review of Batch Production Record from Manufacturing Site• Compile CMC part (Module 3) of Marketing Authorization Application• Regulatory in-puts for Audit and inspections of Manufacturing Site

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  Ranbaxy Lab Ltd, Gurgaon

  Jan 2006 - Nov 2008

  Research Scientist

  • Preparation and review of CMC documents (Module 3) as per ICH guidelines/EU directives/regulations for compilation of New Marketing Authorization Application for generic product in the EU (via National/MR/DC Procedure) • Preparation of variation application (CMC) for any change in existing marketing authorization• Preparation of renewal application for marketing authorization in the EU• Response to deficiency letters/ queries received from the Health Agencies during ongoing assessment• Review of Drug Master Files (DMF) for Drug Substances sources• Providing regulatory in-puts for product development of generic drug formulations Show less

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  Novartis

  Dec 2008 - Oct 2013

  Global Maintenance Regulatory Manager

  • Preparation and submission of renewal application for products registered in the EU (via National, MR/DC Procedure and CP)• Preparation and submission of safety variations to update Product Information based upon safety changes coming from CDS update or other sources e.g. class label, referrals, PSUR assessment reports• Responsible for preparation of response to queries/comments received from Health Authority (HA) during Renewal assessment, variation assessment, PSUR assessment etc.• Regulatory contact for the EU referral procedures related activities to achieve the best possible labelling in the EU• Coordinate with Novartis Affiliates/ regional offices to achieving regulatory compliance and audit preparation• US labelling activities e.g. Physician Labelling Rule (PLR) format update, labelling supplements, response to the FDA queries/ amendment to prior approval supplement• Preparation of regulatory documents for IND/NDA Annual Reports for the FDA submission• Assists in the development of best practices for Regulatory Affairs process Show less

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  Novartis

  Dec 2013 - May 2023

  Senior Global Program Regulatory Manager - Respiratory and Allergy Brands

  • Regulatory strategies for new registration application and license maintenance activities• Preparation and submission of marketing authorization applications, variations and renewals• Regulatory feedback for Periodic Safety Update Report (PSUR), RMP, PADER, IND/NDA AR, DSUR, Clinical Overview etc.• Responses to Health Agency queries• Regulatory feedback for Core Safety Information (CSI)/ Core Data Sheet (CDS) amendment/update• Impact assessment of procedures like Article 31, Article 46, PSUR Assessments, new class label and implementation of outcome in the Product Information/label• Review of labelling, packaging and promotional materials• Preparation of HA communication, Dear Health Care Professional (DHCP) letter• Regulatory evaluation of request for new MA registration, marketing discontinuation or MA deregistration• Planning, preparation, and submission of Clinical Trial Application (CTA) and IND• Maintenance of the CTA during the study life cycle (e.g. amendments, end of trial notifications, DSURs and Clinical Study Reports) and communication with the relevant HAs (as applicable)• Track CTA activities including timelines and milestones and communicate the CTA submissions and approvals• Regulatory feedback for product portfolio review, identify risk/gap and develop a risk mitigation plan to keep uninterrupted supply of medicines• Regulatory in-put during internal and external audits, ensure regulatory compliance• Regulatory lead for divestment/ out-licensing discussion and facilitate the MA transfer to buyer• Training, coaching and mentoring of newly hired employees in Regulatory LCM • Sharing knowledge of Regulatory Guidance and Procedures with cross functional team • Transfer of regulatory activities from across different sites in Novartis• Monitored the process, identified scope of improvements and provided progress/status update to the relevant Regulatory Leadership forums.• Hiring and on-boarding of external and internal resources Show less

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  Takeda

  May 2023 - now

  Director, Global Regulatory Affairs-CMC Sourcing

  • Manage and ensure continuous optimization of the outsourcing model. • Communicate actual or potential issues and present solutions on time. • Measure efficiencies, productivity, and look for opportunity to add strategic and operational innovation.• Supplier management activities oversight, focusing on building strong contractor relationships and delivery of defined projects.• Manage global collaborations with staff members and cross functional teams.• Contribute as an extended leadership to the Global Regulatory Affairs CMC leadership team. Show less