Regulatory Operations Compliance

Michael Martin Sauter

Regulatory Operations Management Executive

*******@*****.*** • 781-***-****

LinkedIn URL • Greater Boston Area, MA

Strategic leader with a proven track record of optimizing regulatory operations to ensure compliance and drive organizational efficiency. Recognized for navigating complex regulatory landscapes and implementing streamlined processes that enhance productivity and mitigate risk. Expertise in developing and executing regulatory strategies, fostering cross-functional collaboration, and delivering results in highly regulated industries. Adept at leading teams to achieve operational excellence and exceed regulatory expectations. Committed to driving continuous improvement and maintaining a strong commitment to regulatory compliance.

Areas of Expertise

Risk Assessment and Mitigation

Regulatory Strategy Development

Regulatory Landscape Navigation

Regulatory Compliance

Continuous Improvement

Team Building and Leadership

Strategic Planning

Process Optimization

Operational Excellence

Professional Experience

Axogen Inc, remote

Senior RIM SME (Contractor, short term assignment) 9/2024

●Sr. RIMS Implementation SME. Responsible for spearheading all data clean up, planning, organizing and review for everything in regard to the RIMS Implementation. This will include monitoring and ensuring compliance throughout the process.

FMS Consulting, LLC, Boston, MA

Senior Project Manager (Contractor), Digital for Regulatory at Moderna 6/2023 – 6/2024

Enhanced efficiency across Regulatory Operations, and Project Management functions with comprehensive digital solutions. Enabled seamless execution of IT initiatives for regulatory compliance by providing project management support.

Key Achievements:

●Achieved 30-50% acceleration in regulatory processes through the implementation of automation and AI.

●Optimized resources and drove cost-effective advancements in regulatory operations through innovative digital strategies and actions.

Alexion (An AstraZeneca Company), Boston, MA

Senior Director, Global Regulatory Operations, and Regulatory Project Management 2019 – 2023

Fostered a skilled workforce capable of managing simultaneous global submissions through talent development programs. Optimized systems governance and prioritized investments across the technology portfolio by leading content and data management strategies.

Key Achievements:

●Saved $1 million (30% of budget) by outsourcing 80% of publishing, while maintaining high operational standards.

●Ensured compliance readiness and seamless data management for inspections through RIM/Promo Mats solution implementation.

●Heightened regulatory compliance and process efficiency through continuous improvement initiatives.

●Reduced error rates in documentation by developing and enforcing standardized submission processes.

●Enhanced compliance and accelerated approvals across global health authorities by spearheading eCTD submissions.

Sarepta Therapeutics, Cambridge, MA

Senior Director, Regulatory Operations 2019

Enhanced internal disciplines and contractor performance in submission preparation through training and support. Streamlined processes and improved team efficiency by developing work instruction documents for electronic submission readiness. Contributed to successful preparation of diverse submission types by supporting various task force activities.

Key Achievements:

●Ensured compliance and readiness for regulatory inspections through the successful implementation of a Regulatory Information Management (RIM) solution.

●Enhanced accuracy and completeness of submissions by developing robust processes and strategies for electronic submission preparation.

●Bolstered regulatory compliance by leading the publishing team in meeting health authority, ICH, and other standards organizations’ requirements.

Mallinckrodt Pharmaceuticals, Bedminster, NJ

Senior Director, Regulatory Operations and Global Labeling 2016 – 2018

Fostered innovation and continuous improvement, aligning technology platforms, and driving strategic business goals forward through implementation of transformative initiatives. Drove standardization and efficiency gains across organization by leading migration to Cloud-based systems for document management and artwork labeling. Enhanced agility and compliance readiness by facilitating transition to electronic submission, marking a pivotal milestone in regulatory operations.

Key Achievements:

●Boosted efficiency and synergy across operations by orchestrating seamless integration of four acquired companies, establishing a unified Regulatory Operations team.

●Mitigated risk and ensured operational continuity by successfully deploying RIM/Promo Mats solution, ensuring regulatory compliance and inspection readiness.

●Optimized productivity and compliance by spearheading implementation of innovative IT systems for document management, labeling artwork, and Regulatory Information Management (RIM).

●Drove strategic growth initiatives by positioning the Regulatory PMO team to support successful submission of first NDAs for new business segments.

●Ensured compliance and operational excellence by developing and executing comprehensive Regulatory Quality Strategy, fostering robust capabilities in NJ Office Regulatory Operations.

Biogen, Inc., Cambridge, MA

Senior Director, Digital Health Technology and Innovation 2015

Spearheaded R&D wide Digital Health and Big Data initiatives for a global biotech company, driving innovation and fostering collaboration. Revolutionized drug development processes and accelerated time-to-market for new treatments with development and implementation of data-driven decision tool.

Key Achievements:

●Enhanced decision-making processes and innovation, resulting in streamlined operations.

●Elevated brand recognition and market influence, positioning Biogen as a global thought leader in Digital Health through strategic partnerships with startups and academia.

●Expanded revenue streams and optimized commercial performance of key Multiple Sclerosis asset through impactful comorbidity drug impact RWE analysis.

●Maximized patient outcomes and advanced research in critical areas such as ALS, Alzheimer's, and Dementia by integrating mobile and monitoring devices into clinical trials.

Biogen, Inc., Cambridge, MA

Senior Director, Global Regulatory Affairs Head of Global Regulatory Operations 2008 – 2015

Led regulatory affairs efforts in RIM, IDMP, and cloud-based authoring systems, ensuring successful regulatory inspections and establishing a disciplined electronic management solution. Developed, drove, and led the Biogen Global Regulatory Operations team, ensuring top-tier performance and industry leadership in electronic submissions. Guided local efforts in developing guidelines, tools, and testing for electronic submission, fostering industry-wide advancements, as a key advisor named by regulatory agencies globally. Elevated Biogen's visibility in the Digital Health space through media outreach efforts, preparing executives for interviews, and collaborating on social media strategy with Public Affairs.

Key Achievements:

●Achieved millions of dollars in savings, 100% regulatory compliance, and industry leadership in electronic submission through the implementation of a fully integrated Regulatory Information Management (RIM) solution.

●Realized significant time and cost savings, enabled real-time global inspection readiness, and streamlined processes by spearheading the company-wide transition to Electronic Trial Master File (eTMF).

●Established Biogen as an innovative leader in Digital Health, accelerating R&D and securing a "first-move" advantage in the market through strategic partnerships with Google, IBM, and academic institutions.

●Expanded Biogen's presence with transformative applications and pilot projects in Digital Health and Big Data, accelerating R&D and securing a "first-move" advantage in the market.

Additional Experience

Director / Associate Director, Regulatory Operations, Biogen, Inc., Cambridge, MA

Director, Clinical Informatics, Clinical Research Division, Pfizer Global Research & Development, Ann Arbor, MI

Information Systems Manager, Regulatory Systems and New Technologies, Sanofi Pharmaceuticals, Inc., New York, NY

Project Leader – Senior Programmer/Analyst, Pharma Dev. Informatics, Hoffman-La Roche Inc., Nutley, NJ

Programmer/Analyst II and Chemist, Chemical Process Development, F. Hoffman-La Roche AG, Basel, Switzerland

Education & Credentials

Certificate, Big Data and Social Analytics, MIT, Cambridge, MA

Certificate, Business Practices, New York University, New York, NY

Master Class, Digital Leadership, MIT Sloan School of Management, Center for Information Systems Research

Systems Engineering and Structured Analysis and Design, F. Hoffman-La Roche AG, School of Information Management, Basel, Switzerland

Chemical Laboratory Assistant (Swiss Federal Vocational Education Program – Equivalent to bachelor’s degree), F. Hoffmann-La Roche AG, Basel, Switzerland

Events

6th Annual Regulatory Operations and Submissions: Panel Discussion: Exploring the Next Generations of Regulatory Operations

Deloitte: Boston Data Science Forum; Presentation: Creating Real Value in R&D with Data Science

LogiPharma: Keynote Address on New Ways to Use Digital Technology and Data Analytics to Deliver Customer-First Experience

Drug Information Association: Regulatory Submissions, Information, and Document Management Forum - Impact of Digital Health on Regulatory Information Management

Partnership in Clinical Trials: Chairperson of Innovation Track

HealthXL Workshop on Consumerization of Digital Health: Pharma User Case

Clinical Systems and Tech Marketplace: Value of Digital Technologies in Clinical Trials - Accelerating Research or Making Patients' Lives Better?

Business and Higher Education Forum (BHEF): Value of Data Sciences in Pharma

DIA Europe: Annual eDM Conference - TMF as Knowledge Management Catalyst

PMDA, Tokyo, Japan: Lecture on eCTD in Japan vs. USA/EMA

LORENZ User Group Meeting Japan, Tokyo: Presentation on e-sub status in the USA

Professional Memberships

Health XL PhRMA DIA EFPIA BIO RAPS

Languages

English, German, French

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