F. Hoffman-La Roche AG, Basel, Switzerland

MIT Sloan School of Management, Center for Information Systems Research

University of Michigan, Executive Education Center

Coursera

F. Hoffman-La Roche AG, School of Information Management, Basel, Switzerland

Driving Compliance Excellence: Seasoned Regulatory Operations Management
Executive Transforming Governance & Efficiency

I significantly enhanced efficiency across Regulatory Operations and Project Management functions by implementing comprehensive digital solutions. My role involved seamlessly executing IT initiatives for regulatory compliance, providing crucial project management support. Noteworthy achievements include accelerating regulatory processes by 30-50% through automation and AI integration. Additionally, I optimized resources and drove cost-effective advancements in regulatory operations by spearheading innovative digital strategies.

fms LLC

Senior Contract Project Manager, Digital for Regulatory at Moderna (c)

Alexion Pharmaceuticals, Inc.

Senior Director, Global Regulatory Operations, and Regulatory Project Management

Sarepta Therapeutics

Sr Director Regulatory Operations

Interim, temporary substitute high school teacher, chemistry and physics

Scituate Public School

Substitute High School Science Teacher

Recruited to lead Regulatory and Labeling Operations for a $3B Branded global Pharmaceutical and Generics company. Report to the VP, Regulatory Affairs. Currently supervise 8 direct reports.

Headed and built Branded Regulatory Operations team while integrating four recently acquired companies. 

Decisively defined and anticipated strategic, market and operational needs and translated those needs into effective regulatory operational processes and Best-In-Class technical solutions. 

Analyzed workload and demands, collaborated with senior management to define NJ staff, roles, and processes, and decided on in-house or outsourced solutions.

Built united team and put in place consensus-based solutions and practices.

Led integration of multiple separate infrastructures and creation of standard operating procedures while ensuring continued world-class Regulatory/Labeling support for a $3B global product portfolio. 

Built Regulatory Operations organization and capabilities, including Regulatory Information Management, Identification of Medicinal Products, Regulatory Performance Framework. Led team in all Regulatory Operations-related diligence tasks. Harmonized and streamlined processes, IT systems, support models, Service-Level Agreements, and in-/out-source models.

Implemented three major IT systems. Positioned Regulatory Operations Group to publish submissions electronically for the first time.

Effectively supported leader-driven strategy implementation. Developed wide and deep relationships with internal and external stakeholders and decision-makers. Built and executed long-range technology strategies for relevant business areas. Supported business strategy planning.

Drove innovation and delivered continuous improvement and transformations: leveraged leading edge technologies from ideation to proof of concept. Jointly harmonized and aligned IT platforms of recently-acquired companies with in-house systems and ensured reliable data migration.

Mallinckrodt Pharmaceuticals

Senior Director, Regulatory and Global Labeling Operations

YourEncore

Expert

Senior Consultant for regulatory operations and technology projects.
Part-time.


Always looking for additional project work!

27Q, LLC

Sr Consultant, Regulatory Operations & Technology, part-time

Led and drove enterprise-wide Digital Health and Big Data initiatives for a global biotech company ($12B+ in annual revenues, @7,500 employees, 25+ global locations). Reported to the Executive VP and to the CEO.

Positioned Biogen as a thought leader: partnered with startups and academia, presented at high-profile conferences.

Co-led Digital Health Technology strategy: fused innovative business practices, advanced analytics to R&D priorities. 

Led production of an innovative data-driven decision tool with a first-ever ability to match drugs under development to known diseases based on specific genetic sequencing information, mechanism of action, and disease database. This tool effectively supported fact-based decision-making for indication selection for clinical program(s) and was adopted across Biogen as a standard operating procedure.

Led Real World Evidence (RWE) analysis project to identify new possible indications for existing assets. Led comorbidity drug impact RWE analysis on key commercial MS assets. Used clinical data to find potential new uses for existing drugs. 

Researched mobile and monitoring devices for clinical trial projects, including ALS, Alzheimer, and Dementia.

Biogen

Senior Director, Digital Health Technology and Innovation                                           

Developed, drove, and led Global Regulatory Operations team. Awarded the FDA Group 
Recognition Award. Emerged as “The Face of Biogen” on industry working groups. 
Led strategy and early implementation of a fully integrated, company-wide Regulatory 
Information Management (RIM) solution. 

Delivered millions of dollars in savings, set up ongoing successful regulatory inspections, and 
established a disciplined electronic management solution for a massive trial master paper 
archive.

Created single integrated Regulatory Operations database linked to Supply Chain and 
Manufacturing: drove 100% regulatory compliance, made Biogen industry leader in this 
area.
Built globally respected top-performer team recognized by leading U.S. and foreign government 
regulators as an industry leader in electronic submission. Name-requested by foreign regulatory 
agencies to advise local electronic submission efforts

Led company-wide implementation of Electronic Trial Master File (eTMF) and conversion of 
paper files into eTMF: achieved significant time and cost savings.

Led Digital Health and Big Data pilot projects with enterprise-wide impact. Entrusted by CMO 
and EVP of Technology to lead Biogen’s first-ever effort to establish and cultivate a strong 
network of global relationships in the digital health space. Aggressively expanded Biogen’s 
presence as an innovative leader with “first-move” advantage and transformative applications 
that accelerated R&D.
Identified, cultivated, and built powerful network of strategic market-leading partners, including Google, IBM, U.S. Department of Veterans Affairs, University of California, MIT, and others. Communicated with Apple and Intel.
Partnered with Line of Business leaders to develop strategy, value proposition, needs assessments, and research plans for Digital Health, transformative technology, and RWE analytics.
Closely supported media outreach by EVP of Technology to gain global visibility for Biogen’s Digital Health initiatives.

Senior Director, Global Regulatory Affairs / Head of Global Regulatory Operations, Knowledge & Infor

Led Regulatory Operations Group to global recognition as a pioneer in the implementation of electronic filings and digital tools. 

Produced first-ever regulatory submission in Electronic Common Technical Document (eCTD) format. Retrofitted imperfect submission, won FDA and PEI recognition, and proved the validity of eCTD submissions. 

Led and grew cohesive global team that produced and submitted multiple electronic regulatory filings abroad and developed technical expertise in Records, Knowledge, and Development Sciences information management.

Partnered with Financial Planning & Analysis leadership to strengthen proactive budget management: successfully stayed within 3-5% of budget and reduced maintenance burden on regulatory leadership.

Director / Associate Director, Regulatory Operations                                            

Oversaw all Clinical Research electronic regulatory submission deliverables. Coordinated 
timelines, workflow, and outsourcing. Participate on all submission task forces. 

Managed group with oversight of electronic regulatory submissions, medical dictionaries, and 
clinical IT projects. Ensured efficient and timely distribution of PD dictionaries to business 
partners and CROs.

Warner-Lambert / Pfizer

Director Clinical Informatics

Managed and oversaw development and execution of all US regulatory, safety surveillance, and 
quality assurance systems. Reported to the VP IS/CIO. 

Led Implementation of computer systems validation function. Implemented electronic 
document management system for regulatory files and record archiving. Managed 
implementation of MedDRA dictionary for Safety Surveillance.

Michael Sauter