DESSY A. TASLIM-NAKAI
Irvine,CA
Summary
Regulatory affairs professional with comprehensive expertise in navigating complex regulatory landscapes and ensuring compliance. Proven ability to drive successful submissions and approvals for critical projects while fostering collaborative team environments and adapting to evolving regulatory requirements. Reliable in delivering results and maintaining high standards.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Regulatory Affairs Specialist
Simply Good Foods Company
09.2021 - Current
- Developed and implemented regulatory strategies for product submission, ensuring compliance with local and international regulations
- Collaborated with cross-functional teams to streamline processes, reducing time to market
- Conducted training sessions on regulatory compliance for new team members
- Reviewed and approved product labeling to ensure compliance with FDA guidelines
- Monitored regulatory changes and advised the company on implications for product lines
- Generate Nutrition Fact Panel, Ingredient Statement, and PDCAAS Calculation via Genesis to create technical label copy for finished product label
- Perform thorough review of product labeling via Webcenter to ensure appropriate claim use and compliance with labeling regulation in the US, Canada, Australia, and EU
- Review products claim and ensure consistent use of claim across all marketing tools, sales collaterals, and digital commerce (label copy, web content, banner, product campaign, sale sheet, store display material, etc.)
- Apply for finished products certification such as Gluten Free Certification and OU Kosher Certification and maintained the yearly updated schedules for both certification bodies
- Assist in international product registration and the maintenance of the import permits by generating all the necessary documents requested by the importing agencies and distribution companies
- Support and collaborate with R&D, QA, Supply Chain, Marketing, Sales and Consumer Engagement for new product innovation and achieve balance between regulatory concerns, marketing objectives, compliance, time to market, costs, and consumers’ product inquiries
- Manage projects schedules and delegate tasks to team members in order to meet deadlines in timely manner
- Provide training to internal and external team members to ensure the alignment of the standardized process
Regulatory Affairs Specialist
Simply Good Foods Company
09.2017 - 09.2021
- Developed internal compliance documentation to support product development initiatives
- Assisted in the preparation for regulatory inspections, resulting in zero non-compliance findings
- Participated in industry conferences to stay current on regulatory trends
- Engaged with external partners to facilitate product registration in target markets
- Conducted risk assessments for new formulations and product changes
- Design, manage and update internal regulatory database for ingredient evaluation such as Allergens, Prop 65, WADA, Bioengineered Status, GRAS, Safety Datasheets, Gluten Free, and Kosher statuses for accurate finished products vetting
- Reviewed and approved product labels at every stage from initial drafts, digital proofs to first prints as well as marketing materials to ensure regulatory compliance in domestic and global markets, focusing on US, Canadian, EU and Australian labels
- Applied, created, and reviewed all export documentation and full compliance with regulations, including CUSMA, NAFTA Certificate, AQIS, Country of Origin Certificate, Certificate of Quality, Certificate of Free Sales, and Manufacturing’s Statement of Product Compositions
- Conducted research and assisted with preparing and supporting strategic planning and product development efforts, such as generating Technical Label Copies and substantiating of nutrient content claims and health claims
- Collected, evaluated, approved, and updated all raw materials documentation via TraceGains
Regulatory and Scientific Affairs Specialist
Nellson Nutraceuticals, LLC.
12.2016 - 09.2017
- Authored technical documents and regulatory submissions for nutraceutical products
- Evaluated scientific literature to support product claims and safety
- Collaborated with R&D to ensure new product formulations met regulatory standards
- Maintained compliance with international regulations for dietary supplements
- Provide guidance on labeling and advertising claims to marketing teams
- Assisted in product re-formulation to align with updated regulatory requirements
- Ensured compliance with federal and state requirements by interpreting, evaluating and approving food product labels (with a focus on nutrition information, ingredient statements, health declaration, etc.)
- Assisted brand owners in filing certifications for their products, including Gluten-Free Certification, Organic Certification, and Non-GMO Project Verified
- Coordinated documentation support for internal and external customers
- Supported the preparation of required documentation including (but not limited to): Specifications, Ingredient Statements, Allergen Statements, GMO Statements, WADA, Prop 65, Kosher, Halal, Vegan, SDS, Nutrition Information, Country of Origin Information
- Prepared and updated documentation to assist with audits, including third-party, FDA, kosher, non-GMO, and food safety audits
- Monitored current and upcoming regulatory changes within FDA, Canadian Food Inspection Agency, and other regulatory agencies, and related this information to clients and other employees
Flavorist
Gold Coast Ingredients, Inc.
01.2014 - 06.2016
- Developed flavor profiles for new products in accordance with client specifications
- Conducted sensory evaluations to ensure product quality and consistency
- Collaborated with marketing and sales teams to align product offerings with consumer trends
- Managed flavor library and ensured compliance with safety standards
- Assisted in the formulation of flavor compounds for various applications
- Conducted training sessions on flavor development for junior staff
- Created and optimized new and existing formulations that adhere to domestic and international standards, including but not limited to: Organic, Non-GMO, Allergen-Free, Gluten-Free, Whole Foods, Trader Joe’s, Halal, Kosher, European Union, Japanese compliance, etc
- Generated specification sheets and technical reports for new products by conducting tests of specific gravity, pH, refractometry, flashpoint, moisture contents, water activity, brix, etc
- Evaluated formula ingredients for compliance with regulatory, safety, and customer specifications and worked directly with common raw materials used in flavor manufacturing: absolutes, resins, extracts, aroma chemicals, yeasts, hydrolyzed vegetable proteins, amino acids, and essential oils
- Conducted shelf-life studies, reported findings to management, and developed ways to improve flavor quality and integrity
Flavor Lab Technician
Gold Coast Ingredients, Inc.
08.2012 - 01.2014
- Supported the flavor development team in the preparation of flavor samples
- Conducted routine quality control tests to ensure the adherence to specification
- Maintained accurate records for formulations and test results
- Assisted in the documentation and analysis of consumer feedback on flavors
- Participated in collaborative projects with R&D, Application Scientists and Marketing Teams
- Ensured cleanliness and organization of the laboratory environment
- Accurately compounded a broad range of flavors, such as liquid mixture, powder formula, flavor emulsion, spray dry flavor, and extracts, from formulations provided by flavor chemist
- Conducted sensory testing to determine the usage level for flavors and identify the physical, chemical, and organoleptic testing needed to develop product specifications
- Conducted routine calibration, cleaning, and maintenance of laboratory equipment
- Trained and supervised new lab technicians and interns in compounding, packing flavor, creating specification sheets, lab testing (pH, brix, refractory, water activity, and moisture level), and lab safety
Education
Bachelor of Arts - Anthropology
California State University Long Beach
Long Beach, CA05.2008
Bachelor of Science - Dietetics And Food Administration, Food Science
California State University Long Beach
Long Beach, CA05-2008
ServSafe Food Safety Certification -
01.2005
Skills
- Australia and New Zealand Food Standards
- Critical thinking
- FDA regulations
- Food Safety
- Genesis
- GMP
- Global regulatory compliance
- Global Vision
- Health Canada
- International Regulations
- Labeling compliance
- Labeling requirements
- Leadership skills
- Legal compliance
- Microsoft Office Suite
- Organizational skills
- Problem-solving abilities
- Process improvement
- Product labeling
- Quality assurance
- Regulatory strategy
- Smart Sheet
- Technical guidance
- TraceGains
- USDA
- Webcenter
- Workzone
Organizationsandprofessionalsocieties
- Southern California Institute of Food Technologists, 2004-present
- Institute of Food Technologists, 2004 – 2018
- Golden Key International Honor Society, 2004 – 2008
- Student Food Science Society, 2004 – 2008
Affiliations
- Southern California Institute of Food Technologists
Certification
- ServSafe Food Handler's Certification
Languages
Chinese (Mandarin)
Full Professional
Indonesian
Full Professional
Timeline
Senior Regulatory Affairs Specialist
Simply Good Foods Company
09.2021 - Current
Regulatory Affairs Specialist
Simply Good Foods Company
09.2017 - 09.2021
Regulatory and Scientific Affairs Specialist
Nellson Nutraceuticals, LLC.
12.2016 - 09.2017
Flavorist
Gold Coast Ingredients, Inc.
01.2014 - 06.2016
Flavor Lab Technician
Gold Coast Ingredients, Inc.
08.2012 - 01.2014
ServSafe Food Safety Certification -
- ServSafe Food Handler's Certification
Bachelor of Arts - Anthropology
California State University Long Beach
Bachelor of Science - Dietetics And Food Administration, Food Science
California State University Long Beach
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