Xiaoming (Katy) He

Xiaoming (Katy) He Email and Phone Number

Regulatory Affairs Manager @ Mead Johnson Nutrition
United States
Xiaoming (Katy) He's Location
United States, United States
Xiaoming (Katy) He's Contact Details

Xiaoming (Katy) He work email

Xiaoming (Katy) He personal email

About Xiaoming (Katy) He

I'm an experienced, passionate, and driven regulatory professional in the consumer health area. With my extensive training in nutrition science, I deeply understand the complex interplay between lifestyle changes and health outcomes and how innovative, safe, and effective consumer products can improve public health and quality of life. So I find my way to regulatory affairs to help companies introduce such products to the market place, both in the US and globally.Regardless of the type of health product, high-quality science is fundamental to the success of any regulatory framework. I have worked with cross-functional teams with my expertise in labeling, claim compliance, claim substantiation, global registration (licensing), formula review, dossier preparation, submission, renewal, etc.  I love learning new developments about the ever-evolving regulatory landscape and from experts in the industry to gain skills, insight, network, and mentality needed in my everyday role as a regulatory professional.   I will be more fulfilled than ever being able to apply what I've learned to my career in the next 10 years to come. If you're passionate about consumer health and regulatory affairs like I do, please do not hesitate to connect with me.☲☲☲☲☲☲☲☲☲☲☲ ☲☲☲☲☲☲☲☲☲☲☲ ☲☲☲☲☲☲☲☲☲☲☲ ☲☲☲☲☲☲☲☲☲☲☲Specialties: consumer health product, regulatory affairs; etc.

Xiaoming (Katy) He's Current Company Details
Mead Johnson Nutrition

Mead Johnson Nutrition

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Regulatory Affairs Manager
United States
Website:
reckitt.com
Employees:
33871
Xiaoming (Katy) He Work Experience Details
  • Mead Johnson Nutrition
    Regulatory Affairs Manager
    Mead Johnson Nutrition
    United States
  • Mead Johnson Nutrition
    Regulatory Affairs Manager
    Mead Johnson Nutrition Nov 2024
    Makati, National Capital Region, Ph
  • Mondelēz International
    Sr Scientist-Regulatory Affairs
    Mondelēz International Apr 2020 - Sep 2024
    Greater Chicago Area, Il, Us
    • Lead pre- and post-market regulatory activities to ensure product compliance and consistency in regulatory decision across HALLS brand portfolio with various regulatory classification (OTC monograph drugs, dietary supplements)•Develop innovation strategy, identify and assess risks and provide regulatory guidance to cross-functional partners•Proactively engage with different functions including R&D, Quality, MKTG to ensure project outcomes are achieved with high-quality results •Act as a technical expert for Regulatory to deliver technical perspectives to business partners on the needed ingredient, product formula review, and claim substantiation•Evaluate claims/advertising and promotional material, ensuring risks are minimized and communicated•Create, review, and approve product labeling/artwork for 38 OTC SKUs and 8 dietary supplement SKUs•Complete and submit FDA drug listings and annual facility registration • Monitor emerging legislation and trends in the competitive landscape for potential business impact.
  • Leehe Inc.Usa
    Regulatory Affairs Consultant
    Leehe Inc.Usa Jun 2016 - Apr 2020
    Guangzhou, Guangdong, Cn
    ▪️Provide the scientific and regulatory foundation for product formulations, labeling, advertising, social media content, and claims for dietary supplements▪️Dietary supplement regulatory affairs including FDA GMP regulations, NDI & GRAS regulation, claim substantiation, developing dietary supplement labels, label review, labeling compliance; etc.▪️Provide technical expertise for dietary supplement global registration, including dossier preparation, submission, amendments, response to request, etc▪️Research on scientific databases about dietary ingredient safety and efficacy, risk assessment, recent breakthroughs ▪️Create promotional and outreach materials on the current dietary supplement market situation and industry trends▪️Rebrand and reformulate existing products for US and global market▪️Contribute to marketing and sales, import/export procedures▪️Help facilitate communication and negotiations with US brands and manufacturers•Working knowledge of FDA IND/NDA/medical device/OTC monograph/cosmetics regulatory requirements• Trademark and patent application
  • Danutri Medical Nutrition Counseling Center
    Medical Writer
    Danutri Medical Nutrition Counseling Center Sep 2014 - Jun 2016
    ▪️Collect and organize information and graphics on assigned nutrition topics▪️Write or translate nutrition articles▪️Update post/blog periodically on social media platforms such as wechat, Facebook, etc.

Xiaoming (Katy) He Skills

Data Analysis Microsoft Office Clinical Research Scientific Writing Regulatory Affairs Literature Reviews Grant Writing Public Speaking Pubmed Social Media Medical Writing Recipe Development Formulation Trademarks Customer Service Endnote Written And Oral Presentation Skills Website Creation Cgmp Practices Regulatory Submissions Regulatory Strategy Development Import Export U.s. Food And Drug Administration Dietary Supplements Gs1 Ind New Drug Application Global Regulatory Compliance Regulatory Filings Regulatory Agencies Otc Consumer Goods Consumer Health Information Chemistry Cell Culture Molecular Biology Biochemistry Clinical Data Management Western Blotting Science Biotechnology Elisa Biostatistics Public Health Genetics R Nutrition Laboratory Skills Pcr Graphpad Prism Sas Programming Exercise Physiology Translational Research Diabetes Obesity English To Chinese Chinese To English Translation Quality Assurance Quality Control Wellness Coaching Recruiting Copywriting

Xiaoming (Katy) He Education Details

  • University Of Alabama At Birmingham
    University Of Alabama At Birmingham
    Nutrition Sciences
  • Auburn University
    Auburn University
    Food Science And Human Nutrition
  • Sun Yat-Sen University
    Sun Yat-Sen University
    Biochemistry

Frequently Asked Questions about Xiaoming (Katy) He

What company does Xiaoming (Katy) He work for?

Xiaoming (Katy) He works for Mead Johnson Nutrition

What is Xiaoming (Katy) He's role at the current company?

Xiaoming (Katy) He's current role is Regulatory Affairs Manager.

What is Xiaoming (Katy) He's email address?

Xiaoming (Katy) He's email address is xi****@****uab.edu

What schools did Xiaoming (Katy) He attend?

Xiaoming (Katy) He attended University Of Alabama At Birmingham, Auburn University, Sun Yat-Sen University.

What are some of Xiaoming (Katy) He's interests?

Xiaoming (Katy) He has interest in Beach, Hiit, Reading, Swimming, Animal Testing, Cooking, Genetically Modified Organism, Outdoors, Travelling, Music.

What skills is Xiaoming (Katy) He known for?

Xiaoming (Katy) He has skills like Data Analysis, Microsoft Office, Clinical Research, Scientific Writing, Regulatory Affairs, Literature Reviews, Grant Writing, Public Speaking, Pubmed, Social Media, Medical Writing, Recipe Development.

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