Dir. Regulatory Affairs NA / August, 2022 — Present

Spearheaded global regulatory strategy and compliance for cosmetics OTC fragrances all 29 brand products across North America EU LATAM South America and Asia. Directed regulatory functions including SDS creation INCI nomenclature review claims substantiation testing protocols labeling compliance documentation management and audit readiness. Interpreted complex test data (OTC monographs RIPT SPF stability heavy metals PET etc.) to support global product registrations and product substitutions. Ensured global compliance with product claims drug facts and marketing content; reviewed and approved all labeling inserts e-commerce listings and artwork. Led supplier quality system optimization by implementing performance modeling and transparency protocols increasing supply reliability and reducing compliance risks. Registered finished products across multiple platforms: WERCS Sephora Portal CB312 SB484 SmarterX (Nordstrom) Sephora; managed VOC and Drug listing. Oversaw MOCRA implementation FDA drug listings Health Canada DINs TGA product compliance and multi-market dossier development for regulatory filings and ingredient registration in China. Partnered with RD Marketing Planning and Ops to ensure compliant formulas ingredient vetting and labeling from concept to launch. Harmonized regulatory systems across NA business units and international markets streamlining processes for faster unified market entry. Reviewed and approved technical data such as stability reports PIFs COAs and clinical protocols for global regulatory submissions and audits. Served as company representative with global trade and regulatory bodies including PCPC CFTAEU Cosmetic Alliance and health authorities such as FDA Health Canada ANVISA TGA COFEPRIS NMPA and MOH-SA. Developed and authored regulatory protocols for product testing safety assessments and compliance aligned with Health Canada and EU regulations. Ensure compliance with chemical regulations including TSCA (Toxic Substances Control Act) FIFRA in the US and CEPA (Canadian Environmental Protection Act) in Canada. Prepared and presented regulatory strategies and training presentations for cross-functional teams covering topics such as INCI nomenclature labeling updates and OTC monograph compliance. Drafted and submitted INCI declarations and ingredient listings in accordance with EU Cosmetic Regulation (EC) No 12232009 and Health Canadas Cosmetic Ingredient Hotlist. Interpreted and applied OTC monographs to support compliant formulation labeling and drug facts panel development for the Canadian (DIN) and European (CPNP) markets. Led claims substantiation initiatives by reviewing product formulations and clinical testing data to ensure alignment with permitted marketing claims under Canadian and EU regulations. Collaborated with RD and Marketing to ensure all claims were scientifically supported and compliant with Health Canada guidelines EU Annexes and Advertising Standards Authority expectations.

Dir. Regulatory Affairs Quality & Technical / March, 2020 — July, 2022

Led the global regulatory and technical strategy to improve raw material packaging and finished goods supply reliability through end-to-end supplier performance oversight and risk mitigation. Directed the development and implementation of SOPs protocols and compliance programs across raw material suppliers to enhance agility traceability and responsiveness to evolving regulatory landscapes. Strengthened supply chain resilience by increasing visibility into supplier risks and coordinating resolution of critical issues impacting sales compliance and time-to-market. Oversaw global raw material and ingredient registrations through COSMOS NSF and PCPC portals; managed REACH compliance and Annex 14 submissions for China raw material registration. Authored and maintained key regulatory documentation including SDSs Technical Data Sheets (TDS) Product Information Files (PIFs) Certificates of Analysis (COAs) and CAPA reports. Collaborated with Product Development to evaluate and recommend raw materials review RMIs support product testing and create compelling marketing claims and benefit sheets. Provided regulatory guidance across RD Quality and Procurement to ensure new product launches met all internal SOPs and global requirements for claims substantiation safety stability and packaging compatibility. Led cross-functional initiatives to collect analyze and report supplier quality data driving continuous improvement through corrective and preventive actions (CAPAs). Conducted regular performance reviews with the Supplier QA team to enforce quality standards and improve communication escalation and issue resolution processes. Managed technical documentation and registration programs for Ecocert ISO 22716 (Cosmetic GMP) and ISO 9001 certifications. Acted as the regulatory subject matter expert (SME) on global cosmetic ingredients and OTC product regulations maintaining compliance across the U.S. Canada EU China Latin America and ROW. Recognized for strong leadership ownership communication and influence in managing cross-functional projects solving complex regulatory challenges and driving supplier quality excellence.

Dir. Regulatory Affairs QAQC (Global) / November, 2017 — March, 2020

Developed recommended and implemented regulatory and quality systems to ensure company products including OTC drugs cosmetics toiletries and nutritional supplementscomplied with all applicable local federal and international regulations. Led company-wide efforts to uphold and exceed internal quality standards and government expectations across all business functions and product categories. Directed a cross-functional team to maintain and continuously improve the Quality Management System (QMS) supporting cosmetic and OTC drug products including SOPs work instructions change control CAPA and document control systems. Managed product complaint investigations and trend analysis identifying root causes and implementing corrective and preventive actions (CAPA) including Out-of-Specification (OOS) resolutions. Oversaw regulatory compliance for all change control processes including formulation changes labeling marketing material revisions and SOP updates from ideation to commercialization. Directed end-to-end quality oversight for raw materials microbial testing in-process control finished goods and rework validationsincluding protocol development and execution (IQ OQ PQ). Administered company-wide training programs and documentation on cGMP SOP implementation and new regulatory updates to ensure organization-wide compliance and operational readiness. Interpreted and analyzed regulatory developments from global agencies implemented revised internal systems and procedures to ensure ongoing product compliance. Approved all incoming in-process and finished goods; reviewed and authored SDSs raw material validations and product testing protocols. Created and maintained Master Batch Records raw materialcomponent databases and fill assembly documentation. Spearheaded global certifications and licensing efforts including FDA Drug Manufacturing License ISO 22716 ISO 9001 ECOCERT COSMOS USDA Organic HALAL and KOSHER. Achieved a 98.87% ISO 22716 licensing audit score. Led regulatory assessment of product claims label compliance testing requirements and international dossiers for global markets (Canada EU South America Latin America). Reviewed and approved ingredient listings INCI nomenclature product claims legal statements and label formatting. Ensured compliance with global requirements for drug facts marketing and e-commerce materials. Conducted internal cGMP and GLP audits of manufacturing facilities laboratories and domesticinternational suppliers. Authored audit reports analyzed trends and tracked corrective actions to closure. Managed supplier audits and audit response processes including implementation and verification of corrective measures.

Dir. Regulatory Affairs Product Safety & Compliance- Global- / May, 2015 — October, 2017

Direct a quality system and organization which meets and exceeds regulatory requirements while ensuring the highest quality products are distributed to our customers in a cost-effective manner. Manage FDA Inspections and 483Warning letter Responses Regulatory Compliance In-Coming In-Process Final QC Inspection Functions Calibration CAPA Customer Complaints Product Recalls Product Sample Retains Internal Audits and Customer Audits. Oversee Quality Assurance and Quality Control. Evaluate existing standard operating procedures audits procedures record keeping systems etc. and recommend additions or revisions that impact compliance while integrating efficiently with current modes of operation. Interfaces with management in areas of current and future regulations systems and procedures and develops and implements compliance recommendations. Partners with Regulatory Authorities and Government Relations on regional product compliance (internal as well as contract formulas) labeling and registration requirements. Informs Government Relations Legal and International Contract Manufacturing departments of legislation that may affect the cosmetics or direct selling industry and serves as an information resource in the development of strategies to influence the legislative process. Cultivates and maintains working relationships with trade associations government agents and professional peers through various avenues to remain current on pending legislation court rulings and industry plans for compliance. Works to leverage contacts and influences government agencies and the trade regarding promoting the Companys interests. Proactively represents the company at critical trade association meetings (i.e. CIR ICMAD CTFA (Canada) PCPC International Committee). Provides information and direction to internal departments for projects concerning assigned regions for new product development and launch. Interfaces extensively with International Contract Manufacturing group for external product development site compliance and launch. Provides necessary information to Corporate and subsidiary leadership to aid in start-up operations in new international markets; ensures that applicable U.S. and International regulations are understood and provides technical materials and information. Tracks projects that are exclusive to foreign affiliates (non-U.S. projects). Monitors and ensures the products manufactured and sold by foreign affiliates are consistent with the product information packets and regulations.

Dir. Regulatory Affairs & Compliance (Global) / March, 2013 — April, 2015

Directed the Regulatory Affairs function for all domestic and international product launches overseeing technical file creation design control labeling claims review and compliance documentation aligned with regulatory standards and internal specifications. Developed and executed global regulatory strategy ensuring compliance with evolving international regulations and overseeing all submissions for OTC cosmetic and consumer health products. Assessed and approved product formulations for global market acceptance ensuring alignment with international regulatory standards prior to launch. Managed worldwide product registrations for new products line extensions and reformulations including dossier preparation and communication with regulatory bodies. Reviewed and approved all critical technical documentation including master formulas manufacturing instructions packaging specifications stability protocols validation reports and release specifications. Collaborated closely with Product Development Marketing and Packaging teams to ensure product claims testing and labeling met both regulatory and brand expectations. Led the review and approval of advertising and promotional materials across digital print and retail channels to ensure full compliance with applicable claims and marketing regulations. Supervised a cross-functional regulatory team supporting Sales Clinical Affairs QA Operations Legal and IP functions with regulatory input and strategic guidance. Managed external consultants and regulatory contractors for specialized markets and high-risk categories. Led compliance initiatives related to regional and state-specific legislation including CA Prop 65 GMO labeling and alcohol-based product regulatory oversight. Developed and implemented regulatory standards and inspection methods to evaluate precision and compliance of testing measurement and analytical systems including validation of facilities and equipment. Oversaw incident investigations (e.g. OOS results manufacturing deviations) driving root cause analysis CAPA implementation and continuous improvement across quality systems. Directed regulatory registrations and certifications including: DIN approvals with Health Canada FDA Drug Listings for OTC products California Voluntary Cosmetic Registration EPA and Treasury compliance for alcohol-based products VOC product registration State of California EU Cosmetic Product Notification Portal (CPNP) and Responsible Person duties Sephora QVC ROA and other international retailer portals Coordinated regulatory responsibilities for contract manufacturers including audits documentation review compliance training and regulatory validation activities. Acted as the internal Safety Assessor reviewing and certifying finished goods for EU market submission and compliance under Regulation (EC) No 12232009.

Dir. of Regulatory Affairs & Compliance (Global) / October, 2008 — March, 2013

Led global regulatory registrations across APMEA LATAM and ROW for OTC cosmetics medical devices dietary supplements and food products. Directed international submissions and agency interactions (FDA Health Canada ANVISA TGA EMEA EFSA EPA) ensuring compliance from development to launch. Managed dossier preparation and regulatory strategy aligned with REACH Prop 65 SB 484 RoHS CPSIA FHSA and global labeling laws. Provided cross-functional compliance leadership in labeling claims and packaging ensuring alignment with EU 12232009 CPNP and global regulatory frameworks. Oversaw testing and certification processes including stability SPF RIPT heavy metals and allergens per ICH USP and global pharmacopeia standards. Created and maintained regulatory documents: SDS CFS COO Halal Kosher GMO and product registration dossiers. Acted as regulatory lead for REACH and ECHA submissions; ensured compliance with evolving EU chemical regulations. Recognized for global compliance expertise effective authority negotiations and driving seamless product access across key markets.