Fusing strategic dexterity, problem solving, commercial acuity, a global perspective, and success across verticals (regulatory affairs, research, and academia) and sectors (consumer goods, prescription/OTC therapeutics and medical devices), I challenge, enable and unblock organisational growth in highly regulated fields. Thriving in new environments that demand innovative solutions, I am first and foremost, a problem solver, collaborating and engaging broadly to design and deliver strategies and programs that accelerate speed and access to market. This is shown in defending, growing, and opening-up significant revenue lines for some of the world’s largest players in their respective sectors. Unique to my profile is the ability to integrate with scientific, legal, and commercial worlds, retaining focus on the bigger picture while using advanced people skills to understand and resolve issues in facilitating change or negotiating the right outcomes. This is all underpinned by strong personal credibility, presentation and advocacy skills honed over years of external engagement and cross-sector work, exercising carefully curated arguments and deep technical expertise.
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Chief Technical OfficerBon ChargeAustralia -
Senior Director Regulatory Operations & Compliance (Apac), Lead For Anzjak Cluster & Global TrThe Estée Lauder Companies Inc. Nov 2020 - PresentNew York, Ny, UsStrategic senior leadership role, focused on delivering compliance and driving both strategic and operational initiatives, including innovative regulatory strategies and post-market vigilance at local, regional and global levels. Developed robust business cases to secure major investments while effectively controlling expenses and managing budgets. I built and led a world-class team of 21 full-time employees, adept at navigating reform challenges, and managed complex issues requiring innovative, cross-functional solutions. -
Director Regulatory Affairs - Australia, New Zealand, Japan & KoreaJohnson & Johnson Feb 2014 - Oct 2020New Brunswick, Nj, UsEngaged to develop talent while leading innovative regulatory strategy and execution for regulatory compliance initiatives in challenging regulatory environments, including the transition to new labelling requirements, ingredient defense and issues management. Devised compelling, consumer-relevant science-based claims to drive consumer purchase and challenge competitors. Position the function as a strategic business partner and lead a team of 14, including 4 direct reports. Led external engagement at an industry level including sitting on regulatory policy committees. -
Scientific Affairs Manager - Australia & New ZealandPfizer Consumer Healthcare Jul 2010 - Feb 2014New York, New York, UsLeadership role within the ANZ Affiliate and regional regulatory affairs team. Responsible to build commercial acumen across the team and develop regulatory capabilities, strengthen the rigour of several critical GMP related processes and ensure flawless execution of innovative regulatory strategies (including Switch). Led issues management, brand defense and competitor intelligence and oversaw the integration of all regulatory data from Wyeth to Pfizer based systems. -
Senior Regulatory Affairs AssociatePfizer Consumer Healthcare Jul 2007 - Jun 2010New York, New York, UsManaged a diverse Rx product portfolio, including small molecules, biologicals, and vaccines. Led global compliance project for the pharmaceutical, nutrition, and consumer divisions in Australia & New Zealand, including the design, piloting and deployment of Regulatory Operation/CMC/Compliance tools other quality management system elements & processes. -
Regulatory ConsultantRegulatory Concepts Apr 2005 - Jun 2007Developed and implemented tailored regulatory strategies for client needs in the Australian and New Zealand markets for a wide range of categories including Rx, OTC & listed products, medical devices, human cellular therapies, foods, cosmetics and Ag-Vet products. Other responsibilities, included vigilance activities, quality and Good Practice (GXP) activities, acquisition advice and training.
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AcademicUnsw Jan 2005 - Apr 2005Sydney, New South Wales (Nsw), Au• Tutored and lectured medical and biomedical students in Medical and Molecular Microbiology and Immunology at UNSW.• Conducted research in the field, contributing to the academic community and advancing knowledge in the area of Gastro-intestinal infections -
Post Doctoral Research AssociateQueen Mary, University Of London Jan 2002 - Oct 2004London, Greater London, GbLed research to identify novel targets for designer antibiotics with selective toxicity against the gastric pathogen Helicobacter pylori, leveraging work previously conducted in Porphyromonas gingivalis and protease inhibitors. This collaborative effort between QMUL and Medivir
Andrew Harris Education Details
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UnswMicrobiology -
UnswMicrobiology And Immunology
Frequently Asked Questions about Andrew Harris
What company does Andrew Harris work for?
Andrew Harris works for Bon Charge
What is Andrew Harris's role at the current company?
Andrew Harris's current role is Chief Technical Officer.
What schools did Andrew Harris attend?
Andrew Harris attended Unsw, Unsw.
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