Christopher Mauch Email and Phone Number
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Chris is a Senior Manager in Deloitte’s Life Science practice with over 17 years of experience in the medical device and pharmaceutical industry. Chris partners with his clients on strategic initiatives involving business transformation, program management, strategy, and operations within the regulatory affairs and quality assurance functions. He is a versatile professional and experienced leader with polished management consulting skills and subject-matter expertise in the following areas:- Regulatory Affairs and Quality Assurance program management- M&A and Transaction support for Regulatory Affairs & Quality Assurance teams- Business process re-engineering- Organizational design & operating model implementation- Regulatory Affairs strategy- Regulatory Intelligence process optimization- Risk Management & Compliance- EU MDR & IVDR- Digital Health & SaMD strategy- Business developmentChris studied Biomedical Laboratory Diagnostics at Michigan State University. He has lived and worked both in the United States as well as abroad, and possesses a clear understanding of the complex life science industry, global healthcare regulations, and the intricacies of leading successful teams of professionals.
Deloitte
View- Website:
- deloitte.com
- Employees:
- 490451
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Senior Manager – Life Science Regulatory And Quality TransformationDeloitteChicago, Il, Us
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Senior Manager – Life Science Regulatory & Quality TransformationDeloitte Jun 2022 - PresentWorldwide, OoSenior leader in Deloitte’s Life Science practice, focused on Regulatory Affairs Transformation, Strategy and Business Process Optimization. Partner with my clients to manage large transformation programs, solve internal process challenges, and achieve business objectives. Support client leadership while simultaneously leading teams of experienced advisors, managing resource and budget allocation, and driving progress against program milestones to ensure the highest-quality and timeliest delivery.
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Manager - Life Science SolutionsKpmg Us Oct 2018 - Jun 2022New York, Ny, UsManagement Consulting for healthcare and life sciences clients, focused on Regulatory Affairs Transformation, Supply Chain Optimization, and Business Operations. Actively led complex transformation projects for clients by overseeing teams of individuals, managing resource and budget allocation, and driving progress against project milestones. -
Senior Associate - Life Science SolutionsKpmg Us Jan 2017 - Oct 2018New York, Ny, UsManagement Consulting for healthcare and life sciences clients, focused on Regulatory Affairs Transformation. Supported complex transformation projects for clients by driving progress against project milestones to ensure timely delivery.
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Regional Regulatory Affairs Lead - China, Taiwan, Hong KongAbbott Dec 2014 - Jan 2017Abbott Park, Illinois, UsExecuted strategies that assisted in regulation development, successful product launches, and maintenance of Abbott's portfolio of products in the complex emerging markets of China, Hong Kong, and Taiwan.• Engaged and negotiated with foreign regulators to shape and build the market in a proactive nature beneficiary to Abbott’s business.• Assessed and qualified new innovations for practicality and regulatory compliance in the Greater China region.• Managed ingredient submissions and oversaw manufacturing site audits to ensure conformity to local regulations. -
Senior Regulatory Affairs SpecialistAbbott Jun 2013 - Dec 2014Abbott Park, Illinois, UsRegulatory Affairs project management lead for adult and pediatric therapeutics marketed in both the US and international markets.• Developed and implemented regulatory strategies that achieved launches, influenced legislation, and drove products to market.• Developed and finalized approved claims and Ad/Promo for US adult products with division marketing.• Regularly updated US commercial leadership on emerging FDA guidance, rulings, and impact to Abbott.
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Regulatory Affairs SpecialistAbbott Jan 2012 - Jun 2013Abbott Park, Illinois, UsRegulatory project management lead for adult therapeutics marketed internationally.• Developed and finalized approved claims and Ad/Promo for US adult products with division marketing.• Reviewed country regulations, preformed product assessments, and reviewed/approved technical documents and labels.• Managed database responsible for tracking all global projects and their associated timelines.
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Supply Chain Franchise ManagerAbbott Jul 2011 - Jan 2012Abbott Park, Illinois, UsManaged global product volumes as well as global supply, and forecasted inventory targets for GPO's largest franchise that included Kaletra® and Norvir® (530 MM tablets/year).• Managed the Abbott Virology Franchise supply chain team to ensuring effectiveness and cost control. • Established primary data analysis and methodologies to drive clear decision support related to vendor selection, products and supply planning.• Identified and implemented cross-functional improvements and cost savings projects.
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Regulatory Affairs StrategistAbbott Jan 2011 - Jul 2011Abbott Park, Illinois, UsProvided regulatory guidance and research to Abbott US businesses including: Abbott Diabetes Care, Abbott Diagnostics, Abbott Medical Optics, Abbott Molecular, and Abbott Vascular.• Managed internal knowledge and heat map of the global regulatory environment by reviewing and communicating current policies/practices issued by FDA, EMA, etc.• Interacted and collaborated with all Abbott Divisional RA leadership. • Maintained and ensured internal stakeholder confidence by representing the corporate regulatory strategy function as an informed and accessible resource.
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Regulatory Affairs Project ManagerAbbott Jul 2010 - Jan 2011Abbott Park, Illinois, UsProvided regulatory expertise and project management to pharmaceutical research, manufacturing, and marketing for four development compounds.• Held responsibility for the pre-approval assessment of CMC and related information.• Assisted in the planning and registration process of drugs.• Reviewed finished product labels to ensure compliance, adherence to existing product registrations, and harmonization with other labels.
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Research And Development EngineerAbbott Jan 2010 - Jul 2010Abbott Park, Illinois, UsR&D Performance Testing Engineer, responsible for implementing new bench test methods for evaluating coronary stents, balloons, and guidewires. • Worked with testing team to develop performance test plans and cases, and generated test summary reports for management review.• Developed automated test scenarios and environments for performance testing, and reviewed improvements to existing test procedures.• Supported project design, development and deployment activities.
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Regulatory Affairs InternAbbott May 2008 - Dec 2009Abbott Park, Illinois, Us
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Senior System Analyst (Co-Op)Michigan State University College Of Human Medicine May 2007 - May 2008Grand Rapids, Mi, Us -
System Engineer (Co-Op)Michigan State University College Of Human Medicine Mar 2006 - May 2007Grand Rapids, Mi, Us
Christopher Mauch Skills
Christopher Mauch Education Details
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Michigan State UniversityBiomedical Laboratory Diagnostics (Mt)
Frequently Asked Questions about Christopher Mauch
What company does Christopher Mauch work for?
Christopher Mauch works for Deloitte
What is Christopher Mauch's role at the current company?
Christopher Mauch's current role is Senior Manager – Life Science Regulatory and Quality Transformation.
What is Christopher Mauch's email address?
Christopher Mauch's email address is ch****@****ail.com
What schools did Christopher Mauch attend?
Christopher Mauch attended Michigan State University.
What are some of Christopher Mauch's interests?
Christopher Mauch has interest in Science And Technology, Health.
What skills is Christopher Mauch known for?
Christopher Mauch has skills like Regulatory Affairs, Regulatory Requirements, Gmp, Fda, Procurement, Operations, Validation, Strategy, Sharepoint, Regulations, Therapeutic Areas, Clinical Trials.
Who are Christopher Mauch's colleagues?
Christopher Mauch's colleagues are Nikolaos Nikoletopoulos, Katie Leclair, Andreas Loizou, Natasha Stewart-Todaro, Cpa Auditor, Kamilla Tjørn, Archana Raghu, Bassam Fares, Mba.
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