Tanweer Ansari

About Tanweer Ansari

Regulatory affairs professional with about 18 years of experience in pharmaceutical…

Experience

1. Director, Global Regulatory Affairs-cmc Sourcing

   Takeda

   May 2023 — Present · Hyderabad, IN

   Representing Regulatory CMC on the Global Regulatory and Product Teams and other key cross-functional teams including Supply teams to contribute development and execution of global regulatory product strategies.• Leading proactive identification and communication of regulatory CMC submission risks. • Planning and execution of global regulatory submissions, including CMC-related updates and label expansions.• Providing Regulatory CMC contributions in the development and update of the CDS in the context of available supporting scientific data, regulatory guidance and precedent.• Providing Regulatory CMC contribution to ensure effective regulatory agency communications by participation in Core Regulatory and cross-functional teams discussion.• Consistently communicating global regulatory product strategies across the leadership to ensure alignment and shared understanding of expectations.• Orchestrating the execution of global submission plans to ensure timely market access and post-approval lifecycle maintenance strategies to ensure uninterrupted supply of medicines.• Driving development of a centralized database for worldwide regulatory requirements, improving accessibility and compliance accuracy across global teams.• Driving automation of change control assessments by integrating the regulatory database, resulting in faster decision-making and reduced manual effort.• Led the transition management of Global Regulatory Affairs CMC activities to a vendor model, ensuring seamless knowledge transfer and uninterrupted regulatory operation.• Oversaw supplier performance and established strong contractor relationships, driving accountability, service excellence, and continuous improvement.• Championed innovation and efficiency in regulatory operations through process optimization and integration of enabling technologies• Managed and continuously optimized the outsourcing model, including regular review of Statements of Work and monthly billing accuracy.

Education

• WIPO Worldwide Academy, Geneva

  General Courses on Intellectual Property, Intellectual Property Law

• Hamdard University, New Delhi

  B. Pharm & M. Pharm, Pharmaceutical Science

  1998 — 2004

Skills

• Hplc
• Pharmacokinetics
• Validation
• Generic Programming
• Drug Delivery
• Regulatory Requirements
• Pharmacology
• Regulatory Submissions
• Glp
• Anda
• Regulatory Affairs
• Pharmaceutics
• Ectd
• Pharmacovigilance
• Gmp
• Pharmaceutical Industry
• Sop
• Formulation