Stephen Bates
Regulatory Affairs Professional
Mc Donald,PA
Summary
Experienced Regulatory Affairs Officer with 20+ years of expertise in developing effective compliance practices and executing regulatory affairs initiatives in the pharmaceutical, chemical manufacturing, and medical device industries. Improved work streams and provided valuable support to product management and development teams in meeting regulatory requirements. Meticulously maintained and followed up on records of regulatory information and submissions, ensuring accuracy and timeliness.
Overview
43
43
years of professional experience
1
1
Certification
Work History
Director, US Market Access
DIAGNOSTICA STAGO, INC.
01.2023 - 01.2024
- Provided oversight of clinical studies and technology implementation for coagulation and clinical laboratory instruments
- Directed both Regulatory Affairs and Scientific Affairs teams
- Formulated functional strategies for regulatory submissions, test method comparison studies, institutional clinical partners, goals, budgets, and objectives for the organization
- Developed and implemented regulatory compliance policies and procedures
- Responsible for the planning and execution of FDA 510(k) filings and formal responses
- Confirmed compliance with ISO standards and regulations, conducting regular audits and assessments
- Identified risks and concerns early in the process, proactively advising headquarters
- Collaborated with colleagues in France to develop automated solutions for change notifications
- Developed enhanced training for Clinical Research Associates on rare diseases
- Grew successful relationships with FDA officials while negotiating labeling and clearance requirements.
Director, Regulatory Affairs, Product Support – Worldwide, Customer Channels Group
THERMO FISHER SCIENTIFIC (NYSE: TMO)
01.2008 - 01.2023
- Provide strategy and leadership vision for technology implementation at Thermo Fisher global product safety regulatory affairs staff and business associates in foreign countries
- Implemented Regulatory Artificial Intelligence to support the distribution of over 2,300,000 products including: pharmaceuticals, bio-pharmaceuticals, bioactive, excipients, agricultural antibodies, medical devices, diagnostics and instrumentation
- Responsible for international and domestic licenses, permits, product registrations and product labeling claims for over 1,500 medical devices
- Directed an international team of professionals responsible for integrating business systems to assure transactions are in compliance including DSHEA, NLEA, Medical Foods, Medical Device 510K, UDI, DEA controlled substances; FDA labeling of legend drugs, nutraceuticals, OTCs; Research Use Only, cGMP/ ICH standards: GHS chemical hazard communication; dangerous goods transportation and chemical weapon precursors
- Responsible for CA Prop 65, REACH, RoHs, WEEE and Conflict Minerals compliance
- Initiated regulatory compliance audits, performed gap analysis and institute corrective actions.
Vice President of Regulatory Affairs, Quality Assurance & EHS - North America
EMD CHEMICALS INC.
01.2006 - 01.2008
- Led strategic and tactical direction of all government Regulatory Affairs, Quality Assurance, Trade Compliance, Health, Safety, Security and Environmental programs including ISO 13485, ISO 17025 and RC14011
- Directed 35 RA/QA/EHS Associates
- Implemented company-wide performance improvement programs
- Integrated and functionally aligned Regulatory Affairs, Quality Assurance and Environmental Health
- Responsible for product labeling of nutraceuticals, USP actives, vitamins and excipients
- Developed GMP / Validation Master Plan to convert existing plants to IPEC Excipient cGMP
- Directed and provided strategy for FDA GRAS food ingredient and cosmetic toxicology data submissions
- Managed regulatory filings for domestically produced and imported medical device portfolio
- Responsible for internal and external audits and FDA inspection compliance programs
- Established a “Trade Compliance” Group within Regulatory Affairs to focus on transactional documentation associated with imports and exports
- Secured Responsible Care Certification for corporate headquarters and three manufacturing locations
- Established Corporate Computer Based Safety and Quality Management /cGMP Training Program.
Principal Environmental Chemist
ENVIRONMENTAL TECHNOLOGY GROUP
01.2005 - 01.2006
- Developed a Regulatory Affairs compliance consulting practice providing industrial hygiene, training and independent regulatory affairs compliance audits concerning FDA, DEA, OSHA, EPA, and DOT regulated activities for clients in the chemical, biochemical, pharmaceutical and industrial manufacturing operations
- Provided technical support for the remediation of hazardous waste sites and Brownfield development for residential use.
Principal Chemist – Corporate Health & Safety Officer
ROUX ASSOCIATES, INC.
01.2001 - 01.2005
- Directly managed and or assisted in more than 40 site remediation projects for chemical, pharmaceutical, medical and polymer industry clients
- Principal responsible for a compliance audit practice that addressed FDA, DEA, EPA, OSHA and DOT regulatory requirements
- Consulting practice focused on the pharmaceutical, hospital and medical device business segment whose key customers included Pfizer, Astra Zeneca, Bayer, Beiersdorf, Unilever, Motorola and Sharp Pharmaceuticals
- Hospital clients included Long Island Jewish Hospital, North Shore Health Care System and NY Presbyterian Hospital.
Manager of Environmental Engineering & Safety
BAYER CORPORATION (Coatings and Colorants Division)
01.1989 - 01.2001
- Responsible for all aspects of Regulatory Compliance, Product Safety, MSDS, product labeling as well as regulatory management for FDA food contact polymers for this ISO9001 Company
- Obtained wastewater discharge and air emissions operating permits for the construction of a 50M pound powder coating resin manufacturing plant in Columbus, GA
- Performed pre-construction sampling and remediation programs
- Performed research and developed an innovative aerobic up flow biological reactor for the treatment of high load wastewater from polyester manufacture
- Implemented this biotechnology for insitu bioremediation at this Federal National Priority List “Superfund Site”.
Regulatory Affairs Manager
EM Industries
01.1985 - 01.1989
- Managed Government Regulatory Affairs programs for compliance with OSHA, EPA, FDA and DOT for an international pharmaceutical, excipients, industrial and advance electro-chemical company
- Prepared the Radioactive Material Operating and Emergency Manual and served as RSO.
Senior Chemical Safety Inspector
Mount Sinai Medical Center
01.1981 - 01.1985
- Performed safety inspections in clinical research laboratories and operating rooms
- Interfaced with inspectors from Joint Commission on Accreditation of Hospitals and various government agencies concerning GLP and patient care related compliance programs
- Participated in numerous clinical research projects involving clinical drug trials, surgical implants of polymeric prosthetic devices and epidemiological studies involving anesthetics.
Education
Ph.D. - Environmental Chemistry
Greenwich University
Hilo, HI03.1995
Master of Science - Chemistry
Polytechnic Institute of New York University
Brooklyn, NY01.1990
Bachelor of Science - Environmental Studies
St. John's University
Jamaica, NY09.1981
Skills
- Strategic Planning
- Verbal and written communication
- People Management
- Operations Management
- Legal and Regulatory Compliance
- Government relations
- Contract Management
- Content Development
- Corporate Social Responsibility
- Data Analysis
Educationandprofessionaldevelopment
Doctorate of Philosophy, Environmental Chemistry, Greenwich University, Hilo, HI, 1995, Master of Science, Chemistry / Polymer Science, Polytechnic University, Brooklyn, NY, 1990, Bachelor of Science, Environmental Studies / Chemistry / Pharmaceutical Sciences, St. John’s University, Jamaica, NY, 1981, New York Institute of Technology, 1995 – 2006, Adjunct Assistant Professor of Environmental Technology, Environmental Instrumentation, Environmental Chemistry, Environmental Risk Assessment, Water and Wastewater Treatment, Occupational Safety and Health, 40 Hour Hazardous Waste Operations and Emergency Response (HAZWOPER), United States Coast Guard Auxiliary, 2004 – 2006, Flotilla Staff Officer, Responsible for the planning and administration of division programs to support the Coast Guard’s Marine Safety and Environmental Protection Programs., This included support for such things as education programs, spill reconnaissance and sampling, port safety and security.
Patentsandpublications
- 5,888,250, Biodegradable Dry Cleaning Solvent, March 30, 1999, Nominated for the EPA Presidential Green Chemistry Award
- Aerobic Bacterial Degradation of Complex High Strength Wastewater From Condensation Process Polyester Manufacture Using a Fixed Film Up flow Biological Reactor With Bioaugmentation, Proceedings of the 49th Annual Purdue University Industrial Waste Conference, CRC Press Lewis Publishers, May 1994
- Ruco Polymer Corporation – Waste Minimization Program, Proceedings From New York State’s Fourth Annual Pollution Prevention Conference, New York State Department of Environmental Conservation, Albany, NY 6/ 1991
Certification
- Certified Industrial Hygienist, American Board of Industrial Hygiene, 8241, 2002
- Certified Safety Professional, Board of Certified Safety Professionals, 18207, 2004
- Medical Device Certification Program, Regulatory Affairs Professional Society, 09334474
Transferablecareerskillsets
- Pharmaceutical Experience
- Medical Device Experience
- Biotechnology
- Regulatory Affairs
- Medical Center / Hospital Operations
- Certified Industrial Hygienist
- Environmental Health & Safety
- Quality Assurance
- Responsible Care – RC 14001
- Tactical Marketing Expertise
- Branding and Product Positioning
- New Product Development
- Acquisitions, Due-Diligence, Divestiture
- Green Chemistry
- Customer Service
- International Experience
Appliedskillsetaccomplishments
- Unified a Regulatory Affairs Teams across the EU for 4 regions and thirteen countries to develop and implement compliance programs as part of a new ERP project. Develop and implemented regional organization structure and spearheaded company efforts to align businesses to assure transactional regulatory compliance.
- Integrated and functionally aligned Regulatory Affairs, Quality Assurance and Environmental Health and Safety for Four companies and three divisions into a single corporate structure. Formed a new Trade Compliance Group within the Regulatory Affairs Department to manage all import and export controls.
- Employed team management techniques. Communicated strategic and tactical plans throughout all functions. Key Performance Indicator metrics installed to insure shared corporate goals “alignment” both functionally and to individual level. Developed artificial intelligence process for product compliance surveillance.
- Implemented Regulatory compliance programs to prevent potential FDA 483s. Developed structured behavior based safety programs to reduce OSHA Recordable cases from 3 to 0 with “No Lost Time.
Leadershipprofile
RA/QA/EHS Team Leader with a strong reputation in product compliance management, AI technology implementation and effective multi-site data management of manufacturing facilities. In-depth knowledge of US, EU, FTC, FDA, DSHEA, NLEA, DEA, OSHA, EPA and DOT compliance. My progressively increasing responsibilities have been tied to innovative and decisive motivational leadership accompanied by my strong bioscience experience and technical communication skills with specific knowledge to drive compliance through innovation.
Timeline
Director, US Market Access
DIAGNOSTICA STAGO, INC.
01.2023 - 01.2024
Director, Regulatory Affairs, Product Support – Worldwide, Customer Channels Group
THERMO FISHER SCIENTIFIC (NYSE: TMO)
01.2008 - 01.2023
Vice President of Regulatory Affairs, Quality Assurance & EHS - North America
EMD CHEMICALS INC.
01.2006 - 01.2008
Principal Environmental Chemist
ENVIRONMENTAL TECHNOLOGY GROUP
01.2005 - 01.2006
Principal Chemist – Corporate Health & Safety Officer
ROUX ASSOCIATES, INC.
01.2001 - 01.2005
Manager of Environmental Engineering & Safety
BAYER CORPORATION (Coatings and Colorants Division)
01.1989 - 01.2001
Regulatory Affairs Manager
EM Industries
01.1985 - 01.1989
Senior Chemical Safety Inspector
Mount Sinai Medical Center
01.1981 - 01.1985
Ph.D. - Environmental Chemistry
Greenwich University
Master of Science - Chemistry
Polytechnic Institute of New York University
Bachelor of Science - Environmental Studies
St. John's University
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