Summary
Overview
Work History
Education
Skills
Certifications And Awards
Timeline
Generic

Rama Krishna Kandhimalla

Global Program Lead - Global Regulatory Affairs
Holzkirchen

Summary

Dynamic management professional with 15+ years of expertise in global regulatory and compliance leadership within the pharmaceutical industry. Proven track record in EU and US regulatory strategies, risk-based submissions, and Life Cycle Management (LCM). Expert in leading high-performance CMC, Regulatory Operations, and Strategic Project Management teams, driving operational excellence and cross-functional success.

Overview

21
21
years of professional experience
5
5
Languages

Work History

Global Program Lead - Maintenance Regulatory

Sandoz International
02.2017 - Current
  • Championed the development of a high-performing global CMC team, aligning regulatory and compliance objectives with organizational goals.
  • Orchestrated regulatory strategies for global markets, focusing on Onco injectables within Unterach, ensuring compliance and operational excellence.
  • Enhanced team performance through strategic coaching, skill enhancement, and leadership, driving a high-performance culture.
  • Ensured regulatory compliance across EU (EMA) and US (FDA) markets, driving flawless dossier submissions.
  • Participated in high-impact initiatives, including risk-based regulatory submissions, optimizing packaging efficiency, and enhancing Antibiotic manufacturing.
  • Provided regulatory leadership in Life Cycle Management (LCM) projects, including batch release site additions, maintaining global compliance.
  • Implemented risk-based submission frameworks, aligning regulatory strategies with evolving guidelines.
  • Built and maintained strategic relationships with global regulatory authorities, ensuring proactive compliance.

Associate Director - CMC

Eli Lilly
03.2016 - 11.2016
  • Directed global CMC teams, ensuring seamless integration during M&A transitions and optimizing regulatory performance.
  • Enhanced regulatory strategy delivery through proactive change management, coaching, and process optimization.
  • Awarded 'Best Change Management Leader' for executing a flawless business transition from Novartis to Eli Lilly.
  • Mentored and developed high-performing CMC teams, fostering a culture of continuous improvement.

Group Head CMC

Novartis Animal Health
01.2014 - 01.2016
  • Company Overview: Transitioned to Eli Lilly
  • Established and led the Hyderabad Animal Health Global CMC Regulatory team, aligning operations with global vision.
  • Delivered high-impact LCM projects, enhancing product quality and regulatory compliance.
  • Spearheaded data transfer and employee transition during organizational integration.
  • Fostered a high-performance culture through strategic leadership, coaching, and talent development.
  • Transitioned to Eli Lilly

Regulatory CMC Manager I & II

Novartis Health Care Pvt Ltd
06.2011 - 12.2013
  • Managed global product portfolios, driving CMC regulatory strategies and ensuring compliance.
  • Enhanced submission quality and compliance with EU and US guidelines through team development.
  • Participated in high-efficiency CMC projects aimed at improving product quality and submission timelines.

Manager CMC Regulatory Affairs

Alphamed Formulations Pvt Ltd
10.2009 - 06.2011
  • Led the preparation and submission of CMC dossiers for major markets (Brazil, South Africa, EU).
  • Optimized submission processes, enhancing compliance and reducing turnaround time.
  • Coordinated cross-functional teams to ensure regulatory alignment with global standards.

Assistant Manager CMC Regulatory Affairs

Indigene Pharmaceuticals Pvt Ltd
04.2007 - 10.2009
  • Managed regulatory submissions and compliance for multiple regions, ensuring product quality.
  • Coordinated dossier preparation and submission, maintaining regulatory standards.
  • Collaborated with cross-functional teams to ensure efficient product registrations.

Senior Executive CMC Regulatory Affairs

Shantha Biotech Pvt Ltd
08.2006 - 04.2007
  • Prepared and reviewed CMC dossiers for WHO and FDA submissions, maintaining compliance.
  • Conducted stability data reviews, ensuring dossier accuracy.

Executive Regulatory Affairs

Hetero Drugs Ltd
04.2004 - 07.2006
  • Managed regulatory submissions for ANDA and WHO dossiers, ensuring compliance.
  • Reviewed stability data, impurity profiles, and quality documents for global submissions.

Education

Master of Science - Quality Assurance

Dublin Institute of Technology

Bachelor of Pharmacy - undefined

Al-Ameen College of Pharmacy

Skills

  • EU and US Regulatory Compliance (ICH, FDA, EMA)
  • Risk-Based Regulatory Submission Management
  • Life Cycle Management (LCM) Projects
  • Total Product Cost (TPC) Optimization Projects
  • Change Management & Process Optimization
  • Mergers & Acquisitions (M&A) Integration
  • Project Management (Lean Methodologies)
  • Stakeholder Management & Communication

Certifications And Awards

  • "Above and Beyond" Award (3x) for excellence in operational leadership.
  • "Best Change Management Leader" at Eli Lilly for executing a seamless business transition.
  • Certified in Risk Management (FMEA Implementation).

Timeline

Global Program Lead - Maintenance Regulatory

Sandoz International
02.2017 - Current

Associate Director - CMC

Eli Lilly
03.2016 - 11.2016

Group Head CMC

Novartis Animal Health
01.2014 - 01.2016

Regulatory CMC Manager I & II

Novartis Health Care Pvt Ltd
06.2011 - 12.2013

Manager CMC Regulatory Affairs

Alphamed Formulations Pvt Ltd
10.2009 - 06.2011

Assistant Manager CMC Regulatory Affairs

Indigene Pharmaceuticals Pvt Ltd
04.2007 - 10.2009

Senior Executive CMC Regulatory Affairs

Shantha Biotech Pvt Ltd
08.2006 - 04.2007

Executive Regulatory Affairs

Hetero Drugs Ltd
04.2004 - 07.2006

Bachelor of Pharmacy - undefined

Al-Ameen College of Pharmacy

Master of Science - Quality Assurance

Dublin Institute of Technology

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Rama Krishna KandhimallaGlobal Program Lead - Global Regulatory Affairs