ADRIANA SCHULKA
Saint Joseph,MI
Summary
Results-driven Scientific & Regulatory Affairs professional with 20 years of experience in food science and regulatory compliance, including over 4 years at U.S. FDA. Expertise in evaluating ingredients, product labeling, and claims across food, dietary supplements, and cosmetics. Skilled in U.S. and Canadian regulations, risk assessment, and cross-functional collaboration to deliver actionable compliance strategies that foster innovation.
Overview
1
1
Certification
20
20
years of professional experience
Work History
Senior Regulatory Specialist
REGISTRAR CORP
, USA
06.2022 - Current
- Led high-priority projects involving 20+ regulatory reviews in a single week, helping clients avoid an estimated $10K in potential losses.
- Manage an average of 4+ regulatory reviews per week, approximately 30% above team benchmarks, while maintaining a high level of accuracy and attention to detail.
- Independently manage regulatory projects from initial assessment through final recommendations, documentation, and client communication.
- Conduct comprehensive FDA regulatory research and compliance assessments, translating complex requirements into clear, practical recommendations for clients and internal stakeholders.
- Provided regulatory consulting and compliance support for U.S. FDA-regulated products, conducting regulatory research, product and label assessments, risk evaluations, and technical documentation to guide clients across food, dietary supplements, cosmetics, and OTC drugs.
- Reviewed 600+ product labels since 2022, assessing labeling, ingredients, claims, product information, and other applicable regulatory requirements.
- Prepared and developed regulatory dossiers and technical documentation to ensure product compliance and facilitate regulatory decision-making.
- Supported clients facing FDA detentions and compliance issues through regulatory assessments and effective communication with FDA on relabeling options and corrective actions.
- Provide regulatory input to ingredient, labeling, and claims assessments, identifying potential compliance risks and recommending practical solutions.
- Serve as a primary regulatory contact for domestic and international manufacturers, communicating complex regulatory requirements to technical and commercial stakeholders.
Owner / Food Regulatory & Technical Consultant
FLEXAA FOOD TRAINING & ADVISORY
Joinville, Brazil
01.2017 - 11.2021
- Delivered technical, regulatory, quality, and business consulting services to food sector companies, enhancing compliance and operational effectiveness for importers and exporters.
- Advised clients on food regulatory, ingredient, quality, and technical requirements for products, beverages, and food ingredients.
- Evaluated technical and regulatory requirements supporting product development, ingredient selection, commercialization, and compliance.
- Prepared and reviewed product specifications, technical reports, procedures, manuals, and regulatory documentation.
- Supported supplier qualification and approval, including evaluation of Quality, Organic, and Fair Trade certifications.
- Performed technical and market research to uncover food ingredient trends and opportunities, guiding clients in potential portfolio expansions.
- Participated in national and international food industry trade shows, supporting technical discussions, customer relationships, and ingredient opportunities.
- Supported food product development and quality assurance activities.
- Provided training on food quality, regulatory requirements, and compliance practices.
Regulatory & Technical Sales / Business Expert
CA GRAMKOW COMÉRCIO EXTERIOR LTDA.
Joinville, Brazil
01.2012 - 08.2016
- Developed food ingredient import/export business by integrating regulatory, scientific, technical, commercial, and market expertise.
- Launched business segment for organic and natural raw materials in food industry, enhancing product offerings.
- Reviewed technical and regulatory documentation supporting food ingredient import processes.
- Collaborated with suppliers and customers on technical, regulatory, and product requirements.
- Established and developed a business segment focused on organic and natural raw materials for the food industry.
- Reviewed technical and regulatory documentation to ensure compliance with food ingredient import processes.
- Evaluated food consumption trends and identified ingredients for potential inclusion in the company’s portfolio.
- Determined and documented appropriate storage conditions and shelf-life controls for ingredients.
Development Engineer — Food Preservation / Usability & Innovation
WHIRLPOOL S.A. / WHIRLPOOL LATIN AMERICA
Joinville, Brazil
01.2007 - 01.2012
- Led global product development, innovation, testing, and technical projects for food preservation and consumer products.
- Facilitated development and evaluation of new food preservation technologies and product concepts, enhancing product offerings.
- Conducted product performance, usability, and consumer verification testing.
- Executed product performance, usability, and consumer verification testing to ensure alignment with consumer needs.
- Collaborated with international teams on technical evaluation and product development projects.
- Coordinated reviews and updates of product information, including manuals, guides, and labels.
- Applied Six Sigma methodologies to evaluate process variation and improve procedures.
- Coordinated Quality Function Deployment (QFD) activities and provided technical training and mentoring.
Education
MBA - Business Administration
INPG – Sustentare
BrazilB.S. - Food Science / Food Engineering
Universidade Federal de Santa Catarina (UFSC)
BrazilSkills
- Regulatory affairs
- FDA compliance
- Project management
- Regulatory research
- Regulatory documentation
- Product compliance
- Product labeling
- Claims review
- Claims Governance Support
- Food regulations
- Formula/Ingredient Assessment
- Supplier & Ingredient Qualification
- Risk assessment
- Regulatory planning
- Packaging & Product Information Review
- Process Optimization
- Product innovation
- Project management
- Market research
- Cross-functional collaboration
- Cross-functional collaboration
Certification
- Six Sigma Black Belt
- Food Law & Regulatory Compliance
- Food Product Development
- Food R&D Process Management
Languages
- Portuguese, Native
- English, Fluent
- Spanish, Professional
- Italian, Basic
Timeline
Senior Regulatory Specialist
REGISTRAR CORP
06.2022 - Current
Owner / Food Regulatory & Technical Consultant
FLEXAA FOOD TRAINING & ADVISORY
01.2017 - 11.2021
Regulatory & Technical Sales / Business Expert
CA GRAMKOW COMÉRCIO EXTERIOR LTDA.
01.2012 - 08.2016
Development Engineer — Food Preservation / Usability & Innovation
WHIRLPOOL S.A. / WHIRLPOOL LATIN AMERICA
01.2007 - 01.2012
MBA - Business Administration
INPG – Sustentare
B.S. - Food Science / Food Engineering
Universidade Federal de Santa Catarina (UFSC)