Abhishek Bhondave

About Abhishek Bhondave

As a Senior Clinical Data and Regulatory Intelligence Professional with over 12 years of…

Experience

1. Assistant Manager

   Tata Consultancy Services

   Jul 2022 — Present · Mumbai, IN

   Led a high-performing team of 4–5 associates in executing regulatory intelligence tasks aligned with global regulatory requirements (FDA, EU, WHO, etc.). Managed daily huddles and weekly client meetings to align on priorities, address challenges, and ensure stakeholder engagement. Oversaw task allocation, performance tracking, and quality assurance to deliver time-sensitive outputs with accuracy and compliance. Maintained accountability for meeting project deadlines and client SLAs through proactive planning and team coordination. Compiled and submitted weekly and monthly team reports, providing insights into progress, risk mitigation, and key deliverables Fostered a collaborative, learning-driven team culture focused on efficiency, communication, and regulatory excellence Provide global intelligence related to PV, RA, GxP (GMP, GCP, GDP, GLP, DH, DI etc.), medical devices, biologics, ATMP’s, IVD and drug products to address current work priorities and to inform and support the relevant compliance activities. Complete intelligence assessments on regulatory issues that assist to formulate effective problem solving strategies, policies and programmes Facilitate and lead presentations, discussions and forums up to senior management level, which provide intelligence and analysis on emerging trends and risks. Preparation and maintaining reporting requirement portal for all major global health authorities. Providing intelligence of inspection guidelines, LPPV guidelines, inspectors as and when required to client. Authoring of Safety Management Plan (SMP) for reporting requirements of health authorities and Ethics committee as and when required. Providing intelligence inputs to SOP team as and when required. Mentoring the team colleagues as and when required.

Education

• Maharashtra State Board of Technical Education, Mumbai

  Diploma in Pharmacy

  2003 — 2006

• University of Pune

  Masters in Pharmacy

  2010 — 2012

• University of Mumbai

  Bachelors in Pharmacy

  2006 — 2010

Skills

• Pharmacokinetics
• Pharmaceutical Industry
• Sop
• Formulation
• Clinical Research
• Clinical Pharmacology
• Gcp
• Pharmacology
• Pharmacovigilance
• Gmp
• Ich-Gcp
• Pharmaceutical Research
• Validation
• Clinical Trials
• Biotechnology
• Regulatory Affairs
• Lifesciences
• Hplc
• Drug Delivery
• Pharmaceutics