Navin Warier
Houston,TX
Summary
Managerial professional with proven record of streamlining processes and leading high-performing teams. Known for strong analytical skills and commitment to achieving results. Teams rely on collaborative leadership and adaptability to changing needs.
Overview
25
25
years of professional experience
Work History
Manager, Regulatory Affairs
SCRI (A McKesson Company)
Houston, TX
11.2021 - Current
- Provide strategic direction and operational leadership for regulatory programs, guiding cross-functional teams to deliver high-quality, inspection-ready submissions while driving alignment, accountability, and timely execution across the portfolio.
- Strengthen organizational compliance and decision-making by establishing regulatory governance, anticipating and mitigating risks, resolving escalations, and using data-driven insights to shape processes, improve performance, and maintain continuous inspection readiness.
- Develop and elevate high-performing teams by mentoring study start-up staff, fostering a culture of collaboration and continuous improvement, and leading initiatives that streamline workflows, enhance efficiency, and improve cross-functional execution.
- Developed and implemented strategic plans aligning with organizational goals and objectives.
Regulatory Affairs Specialist → Regulatory Affairs Specialist II → Senior Regulatory Affairs Specialist
US Oncology (A McKesson Company)
Houston, TX
01.2018 - 01.2021
- Advanced from Specialist to Senior Specialist through high performance, leading regulatory operations that ensured 100% accuracy, audit-readiness, and full compliance with FDA, GCP, IRB, and HIPAA requirements across a large portfolio of clinical trials.
- Accelerated study startup and improved regulatory quality by driving timely IRB submissions, safety notifications, protocol/ICF amendments, and issue escalations, reducing delays, strengthening documentation standards, and improving inspection outcomes.
- Elevated team capability and operational efficiency by spearheading process improvements, training new staff, mentoring peers, and supporting audits, resulting in more consistent documentation practices, fewer findings, and stronger cross-functional execution.
Research Associate
Texas Heart Institute
Houston, TX
11.2009 - 10.2018
- Advanced cardiovascular repair research by driving the development and analysis of 200+ small-molecule therapeutics, generating high-value data that informed candidate selection and accelerated program decision-making.
- Elevated laboratory performance and team capability by optimizing operations, strengthening scientific rigor, and mentoring cross-functional researchers and students in advanced assays, resulting in faster project turnaround and higher overall productivity.
- Developed standardized operating procedures to enhance efficiency in experimental processes and documentation.
Associate Scientist
Cogenics, Inc.
Houston, TX
03.2009 - 10.2009
- Delivered high-quality qPCR and residual-DNA testing in a short-term contract role, improving product quality and regulatory readiness across preclinical, clinical, and manufacturing programs while optimizing workflows, strengthening documentation accuracy, and mentoring colleagues to elevate team performance.
Sr. Research Associate
Lexicon Pharmaceuticals, Inc.
The Woodlands, TX
08.2001 - 01.2009
- Earned rapid promotion by delivering exceptional scientific output, independently completing 150+ high-throughput client projects while introducing new techniques, optimizing resources, and elevating team performance through operational leadership and facility management that improved efficiency and reduced project timelines.
Education
Master of Science - Molecular Biology
Bowling Green State University
Bowling Green, OHBachelor of Science - Microbiology
Bangalore University
Bangalore, IndiaSkills
- Customer service
- Team leadership
- Time management
- Decision-making
- Strategic planning
- Cross-functional teamwork
PUBLICATIONS
- The Journal of Clinical Investigation - LFA-1 Activation Enriches Tumor-Specific T Cells…, July 2022
- Nature - Use of a Small Molecule Integrin Activator…, September 2021
- The Journal of Biological Chemistry - Small Molecule Agonist of VLA-4 Integrin…, July 2013
- Cardiovascular Research - Myosin Light Chain Phosphorylation Facilitates…, December 2011.
Timeline
Manager, Regulatory Affairs
SCRI (A McKesson Company)
11.2021 - Current
Regulatory Affairs Specialist → Regulatory Affairs Specialist II → Senior Regulatory Affairs Specialist
US Oncology (A McKesson Company)
01.2018 - 01.2021
Research Associate
Texas Heart Institute
11.2009 - 10.2018
Associate Scientist
Cogenics, Inc.
03.2009 - 10.2009
Sr. Research Associate
Lexicon Pharmaceuticals, Inc.
08.2001 - 01.2009
Master of Science - Molecular Biology
Bowling Green State University
Bachelor of Science - Microbiology
Bangalore University