Stefano F. Liparoto, Ph.D. Email & Phone Number

Deerfield, Illinois, Us

Support business objectives in all aspects of Regulatory Affairs and Sustainability for the Vantage products globally. My responsibilities include but not limited to the oversight and accountability for regulatory professionals in personal care, food/beverage and industrial applications. In this role, I am accountable for the development and implementation of global strategies of increasing complexity, and for ensuring that the strategy is designed to deliver a business continuity for our customers and stakeholders.

Chicago, Illinois, Us

Responsible for strategic development and implementation for all policies and programs related to toxicology, chemical hazards and allergens. I am leading the Analytical & Applied Sciences Laboratory Team including microphysical and material science technologies. Along with scientific affairs, I will be responsible for the development and maintenance of a regulatory strategy to support ConAgra's business continuity and consumer safety.

Naas, Ie

A Senior Regulatory and Government Affairs Scientist leading the regulatory and advocacy initiatives for Smoke Flavour(s) Primary Products (and its derivatives) reauthorizations in the UK and European Union. Referred to as best-in-class, overall Global technology SME who has proven success managing complex public policy change management initiatives ensuring business continuity and crisis management. Strong organizational development skills and leadership within trade organizations, leading and communicating to multiple EU Directorate Generals and EFSA. Highly motivational and relevant results oriented leader with coaching strenghts and situational development skills. Strong executive level, including Board level, presentation and communication strengths with an unique ability to dimensionalize business impact.

Naas, Ie

Responsible for overall global regulatory compliance and regulatory affairs of legacy RedArrow division of Kerry. Development and oversight of a regulatory compliance team, consultants and contractors enabling business development and continuity. Major objectives are European Union (re) authorizations of Smoke and Grill Flavors, data integrity, technical and executive development of personnel.

Mclean, Virginia, Us

Serve as point of contact for Global Scientific & Regulatory Affairs supporting Chocolate and Confection Business Units. Primary responsibilities include guidance of innovation programs for global markets ensuring successful transition to regional business units. Additionally responsible for stewardship of existing and emerging issues related to scientific and regulatory changes. Topics of emerging interest include novel or changes to food regulations, classification and limits associated with contaminants in raw or finished materials, e.g. heavy metals, process contaminants and other.• Support business objectives via trade organizations comments and engagement including CODEX (CCFA, GFSA note 161), CCCF, EFSA and trade organizations.• Lead the development of cross sourcing, regulatory and claims tool for primary business markets.• Oversee critical scientific and regulatory horizon scanning topics eg sweeteners, heavy metals and other process related contaminants to manage awareness, business impact and activation charters.• Co-design and develop functional business processes for commercialization stage gate within regulatory functions.• Partner with interdepartmental functions on emerging issues of interest publications.

Purchase, New York, Us

Lead and develop a team of 8 direct reports responsible SME for 100% regulatory compliance of ingredients, formula and product labeling, claims substantiation ensuring that accurate labeling, claims and nutritional information are provided to meet all domestic and international new product initiatives without incidences of product recall due to misbranding or adulteration.Strategic Consulting, including business plan & sales strategy development in accord with JV and go-to Regulatory agencies.• Assure that legality and ingredient/nutrition declarations do not result in product recalls or citations from the FDA or other regulatory bodies. Serve as key contact and SME to Business units to implement and promote SRA policies and audit data and documentation to assure adherence to policies.• Complete product formulation review for legality assessment, ingredient and nutrition labeling in compliance with all regulations and FS&RA policies.• Subject matter expert on Regulatory compliance, partnering with Marketing, PD, Legal and Graphics team, engaging at ideation stages to ensure accuracy and legality of final product labeling and documentation..• Serve as critical business partner with external organizations and represent PEP SRA as Subject Matter Expert in a specific field of regulation or science.• Support International product initiatives, assuring product formulations and labeling are in compliance with applicable regulations and SRA policies.• Provide technical & regulatory support to NGO's and governmental agencies (organic, bioengineering/GMO, nutrition label reform, Prop 65).

Purchase, New York, Us

This position leads the Quaker Food North America Research and Development SRA team responsible for ensuring faultless compliance of all processes within SRA department. Key responsibilities include:• Responsibility for regulatory compliance of all formulas and labeling, ensuring that accurate and complete labeling & nutritional information documentation are provided to meet all domestic and international new product initiatives without incidences of product recall due to misbranding.• Serve as key contact to business units to implement and promote SRA policies and audit data and documentation to assure adherence to policies, so that brand equity is not impacted negatively due to noncompliance determinations by the FDA or international regulatory authorities.• Manage the process and people responsible for assuring regulatory compliance of all labeling and nutritional information for all domestic and international products.• Complete product formulation review for legality assessment, ingredient and nutrition labeling in compliance with all regulations and FS&RA policies.• Assure that legality and ingredient/nutrition declarations do not result in product recalls or citations from the FDA or other regulatory bodies.• Subject matter expert on Regulatory compliance, partnering with Marketing, PD, Legal and Graphics team, engaging at ideation stages to ensure accuracy and legality of final product labeling and documentation.• Subject matter expert to one or more assigned brands to facilitate product launches in a timely and compliant manner and assure that product does not result in a misbranding or adulteration recall.• Partner with external organizations and represent PEP FS&RA as Subject Matter Expert in a specific field of regulation or science.• Support International product initiatives, assuring product formulations and labeling are in compliance with applicable regulations and SRA policies.

Midland, Michigan, Us

 Manage a team of Product Toxicologists. Supervise and develop a team of seven scientists whose institutional experience ranged from 10 to 33 years in environmental as well as mammalian toxicological sciences. Indirectly lead a team of 6 Globally based scientists (EU, Asia) to form a Global Product Safety team of Human and Environmental Health Toxicologists. My corporate objectives were to identify, align and harmonize processes including but not limited to GHS Classification and Labeling, risk assessments, registration test identification, facilitation and support of commercialization activities including innovation support as well as search and reapply for intended uses. As Global Technical Coordinator (Health Product Toxicology), my responsibilities included consensus building and leadership of matrixed colleagues residing in EU, South America and the PACRIM as well as interdepartmental colleagues in Health and Environmental Sciences (HES). As one of five members of the HES Leadership Team and HES Science Leadership, the Health and Environmental Global Technical Coordinators served critical roles in strategy development for innovation, issue management, and commercialization including but not limited to US EPA and REACH activities regulated by ECHA.

Mattawan, Mi, Us

One of 11 Department Leaders. The Immunology Department at MPI Research specializes in biologics characterization from discovery to preclinical to clinical assessments as well as other endpoints of Test Articles associated with Immunotoxicology/Safety Assessments. In two years, we have re-organized and built a team of 19 scientists and professional staff to achieve triple digit growth by addressing customer needs with state-of-the-art technology and expertise. The Immunology Team has developed and validated assays to address ICH S6, ICH S8 Immunotoxicology via Idiff, NK, Splenocyte, and other functional assays including but not limited to Complement function in NHP by Classical, Alternative and MBL pathways. In addition, multiple points of expertise to address phagocytic functional status of granulocytes and other PMNs

Wilmington, Nc, Us

Built and trained an Immunogenicity Team for the characterization of anti-drug antibodies ,ADA, measured by (Biacore SPR). The detection of these ADA can not be assessed by other end-point technologies. Wrote, implemented SOP’s, Methods and Biodesigns for GLP compliance. Managed up to 30 active programs with a staff of up to 8 personnel. Served as Principal Scientist and Project Manager for the validation and production samples analysis of ELISA, ECL and SPR methods. Managed client relationships. Identified and assisted in the coordination of new business opportunities with (3) new client BioPharma Corporations (Market Capitalization >$15BUSD). Negotiated with vendors for rates/service. Invited speaker to two national, professional society meetings. Quality / expertise recognized by client award to PPD twice that was requested pursuant to successful coordination of team activities and research related to a propriety product/protocol with annual net sales ≥$8 billion USD.

Cambridge, Ma, Us

• Responsibilities include the characterization of biological therapeutics and their antigens in preclinical development and clinical trials using biophysical techniques, including thermodynamic properties. Data generated was used in support of regulatory filings to the FDA for molecular characterization and comparability studies. In addition, the development of assays for enhanced throughput and selection of monoclonal antibodies based upon binding kinetics was developed. Served as a member of several cross functional teams which develop and implement strategies for product development and identification. I have served as an ad hoc representative of a business development venture (VC) where my role was to perform technology assessment, due diligence associated with intellectual property and licensing with a major Texas-based cancer center.

Cambridge, Ma, Us

Postdoctoral Fellowship, Jointly Held With Pfizer/Warner Lambert + U. Michigan, Biochemistry

Ph.D., Pharmacology/Toxicology (Receptor Pharmacology)

Education record