Denise Malone Email and Phone Number
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I am an incisive and results-oriented USA & Global Food Industry and consumer goods regulatory and quality executive specializing in strategic issues management. Drives world-wide Food Industry nutrition advocacy in government engagement, corporate sustainability, regulatory & quality compliance by fostering company relationships with government stakeholders for special dietary foods. Accomplishes corporate objectives by building high performance project management multi-functional global teams and efficiently executing complex programs in highly regulated industries for food & beverage, cosmetics, nutrition and medical devices. Career Highlights* Established and led Global regulatory affairs for a newly formed International Division covering OTC, medical device and food industry & nutrition products, including divesture and acquisition experience.*Served as in country head of Regulatory and Quality Affairs for Israel affiliate during transition of new product introductions, hiring new management and supervision of in-country eight person staff.* Established corporate citizenship programs influencing scientific collaborations and partnerships in the China, Vietnam and emerging markets.* Compliance officer for manufacturing operations setting up inspections programs and managing audits from State and Federal agencies.* Implemented global trade association and country affiliate participation within the WHO/FAO Codex Committees and global government strategic meetings.
Roquette America Inc.
View- Website:
- roquette.com
- Employees:
- 5634
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Roquette America Inc.Geneva, Illinois
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Sr. Director Head Of Regulatory AffairsRoquette America Inc. Oct 2018 - PresentLestrem, Hauts-De-France, FrHEAD OF REGULATORY AFFAIRS (OCT2018 – PRESENT)Grow and establish regulatory affairs registration, GRAS, Self-GRAS and on market compliance support for Canada, USA and Latin American areas for products in the category segments of food & feed, pharmaceutical, cosmetics and industrial. These products include polyols, starches, proteins, fibers sweeteners, and pharmaceutical excipients. Develops regulatory strategies for government policy influence and alignment to the business through trade association and agency outreach. Act as the primary contact for government agencies and provide quality assurance support during various audits and manufacturing sites throughout the Americas. Align regulatory strategies globally for the greatest influential impact forward.
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Director, Global Regulatory PolicyAbbott 2008 - Nov 2017Abbott Park, Illinois, UsEstablished Regulatory Intelligence function and led Global consumer product teams to protect business interests with more than sixty country affiliates, R&D, and supply chain establishing one Abbott voice to agencies, and trade associations on product formulations and health policy. Identified and managed global emerging issues with USA and global agencies for foods, consumer products, medical devices and related trade association positioning. * Built global government outreach strategies Intelligence department based internationally functioning with affiliates in Asia, Europe, and the Americas. * Served as Head of Regulatory and Quality Affairs for ISRAEL 66MM affiliate during country transition of new product introductions, hiring new management and supervision of eight person staff. * Led programs for Japan Pharmaceuticals and Medical Devices Agency for combination products in and established global Enteral Device product for division including first drug combination product.* Built and fostered relationships with global industry associations to influence global food legislation and policy with a single company position within WHO/FAO Codex Alimentarius Committees and meetings. * Established Corporate Citizenship activities for China, Vietnam, embassy outreach and emerging markets improving country relationships and establishing citizenship relationships to shape local policy. -
Global Regulatory Head, Director International Regulatory AffairsAbbott 2002 - 2008Abbott Park, Illinois, UsEstablished a new regulatory department to support an Abbott Laboratories new International Division venture. Managed budgeting and domestic/international staff ensuring successful registration and product compliance in all global regions including Europe, Asia, and the Americas. Led Regulatory team through numerous division organizational changes with zero business disruption for enteral nutrition and class II medical devices & infusion pumps. Initiated and led division regulatory affairs meetings in Europe, Asia, and Latin America for regional affiliate countries, risk mitigation and training programs. * Working as the International Regulatory Head established and structured the regulatory affairs department as separated from the Abbott Pharmaceutical Division. * Managed 14 Division reports and 60 in-country reports, global budget* Regulatory Affairs subject matter expert in areas of divestures and acquisitions. * Established Regulatory Operations department to capture metrics and reorganized personnel reducing registration time for products by 20%.
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Associate Director, Manager Regulatory Affairs, Abbott InternationalAbbott 1999 - 2002Abbott Park, Illinois, UsLed product lifecycle management encompassing Consumer Products, Medical Nutrition and Device teams from conception through commercialization. Managed Regulatory Associates to represent division on global project teams. Evaluated new ingredients, manufacturing changes, new legislation for global product Quality and Regulatory compliance. * Increased regulatory compliance through the alignment of international regulatory requirements, risk mitigation and contingency plans within 6 months of implementation.Prior Abbott Laboratories Tenures Include:Division Quality AssuranceCompliance Officer / Microbiology Supervisor
Denise Malone Skills
Denise Malone Education Details
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Michigan State UniversityFood Law -
Lake Forest Graduate School Of ManagementMaster Of Business Administration (Mba)
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Michigan State UniversityMicrobiology
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Ferris State UniversityPharmacy
Frequently Asked Questions about Denise Malone
What company does Denise Malone work for?
Denise Malone works for Roquette America Inc.
What is Denise Malone's role at the current company?
Denise Malone's current role is Global Regulatory Affairs|International Government Affairs & Policy|Food & Feed|Consumer Goods|Medical Products.
What is Denise Malone's email address?
Denise Malone's email address is de****@****ott.com
What is Denise Malone's direct phone number?
Denise Malone's direct phone number is +184765*****
What schools did Denise Malone attend?
Denise Malone attended Michigan State University, Lake Forest Graduate School Of Management, Michigan State University, Ferris State University.
What are some of Denise Malone's interests?
Denise Malone has interest in Ross Products Division, Microbiology Supervisor, Sturgis, Prior Abbott Tenures, Abbott Nutrition, Compliance Officer.
What skills is Denise Malone known for?
Denise Malone has skills like Regulatory Affairs, Fda, Cross Functional Team Leadership, Quality Assurance, Pharmaceutical Industry, Quality System, Gmp, Product Development, Strategy, Biotechnology, Leadership, Food Safety.
Who are Denise Malone's colleagues?
Denise Malone's colleagues are Pauline Delassus, David Delettre, Manjunath Patil, Vaibhav Pancholi, Alexandra Queiroz, Joaquim Alves Ribeiro, Becquart Frédéric.
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