Arianne Lindsey, Pharm.D.

Building AI/BI/RIM/eQMS/PD/MA/Labeling/Artwork/Publishing/Distribution/Compliance systems & providing Expert RA Consulting & Gap Analysis by leveraging global regulatory and quality leadership with a 360° perspective—built on foundations at the FDA, senior roles across small to large-tier life-sciences companies, and advisory positions with private equity and trade associations. Currently accepting clients. Expert in determining the regulatory classification and pathway of any product based on intended use and claims—including drugs, biologics, medical devices (Class I–III), combination, IVD diagnostic, SaMD, OTC, cosmetics, dietary supplements, and homeopathic —with precision across U.S. FDA, EU, and global frameworks. Combines regulatory intelligence, strategic labeling, lifecycle management, and quality systems integration to transform compliance into a competitive advantage. Regulatory Law & Guidance FD&C Act · DSHEA (21 CFR 111) · FTC Act · FSMA/FSVP (21 CFR 117) · 21 CFR Part 4, 210/211/820 · QMSR 2026 & ISO 13485 · 505(b)(1)/(b)(2), 505(j) ANDA, and 351(k) BLA pathways · 21 CFR 314/312/600/601 · 21 CFR 803/806/807/809 · 21 CFR 101/201 & 700–740 (Cosmetics) · CARES Act/OMUFA/PDUFA/GDUFA · ICH Q3A–Q3C, Q7, Q9–Q12, M7, E6(R3) · ISO 14971 / IEC 62304 / 60601 / 62366 (HFE) · MDSAP / EU MDR / IVDR Drug–Device Combination (DDC) HFE & Usability Studies · Design Control (21 CFR 820.30) · Clinical & Biocompatibility Design · DMR/DHF · Combo Product Reporting (21 CFR 4b) · FDA OCP & CDRH/CDER Interface · Bridging & Performance Studies · Digital Health Integration · EU Notified Bodies / CE Marking conformity assessments Advertising, Claims & Labeling Physician Labeling Rule (PLR) · FDA/FTC Ad-Promo Guidance · CPSC (16 CFR 1500/1501) · 16 CFR 255 & 260 (Green & Endorsement Guides) · Qualified & Nutrient Claims (21 CFR 101.13/101.14) · Prop 65 · Drug/Supplement Facts (21 CFR 201.66 / 101.36) · Global Labeling (CCDS, USPI, SmPC) · DSCSA Serialization & SPL Listings

Selected to join Chief, the premier private network for senior women executives representing 77% of Fortune 100 companies. Contribute to peer advisory groups and executive leadership programs advancing women in executive and board roles. Shape thought leadership and policy discussions while expanding strategic networks across industries.

Served on the Novo Holdings Board, performing dossier transfer of ownerships, due diligence advising on compliance, acquisitions, and integration to preserve enterprise value. Directed global regulatory, quality, and distribution operations across manufacturing, outsourcing, and 503B facilities under GxP (GMP/GDP/GCP/GLP) frameworks to ensure patient safety and uninterrupted supply • Guided executive and commercialization teams as regulatory lead, driving launch strategy, tech transfers, registration pathways, and post-approval optimization • Served as primary FDA/DEA/BOP liaison and Management Representative, leading inspections, recalls, and CRL responses with consistent favorable outcomes • Managed global product licensing, registration, and distribution for ~1.5 billion sterile doses annually, maintaining DSCSA, DEA, and state Board of Pharmacy compliance • Directed FDA reporting for drugs and medical devices, including AERs, PADERs, FARs, MDRs, and Field Corrections/Removals to ensure regulatory transparency and patient safety • Led major facility expansions, adding GMP-compliant warehousing, laboratories, and distribution infrastructure to enhance long-term growth and capacity • Harmonized enterprise QMS to ISO 13485, MDSAP, and 21 CFR 111/210/211/820; embedded ICH Q9 and ISO 14971 risk-management principles • Implemented enterprise RIM/QMS digitization to streamline submissions, change control, and lifecycle compliance. Core Competencies • Strategic Vision • Corporate Governance • Financial Acumen • Succession & Exit Planning • Regulatory Compliance • Market Growth • Strategic Planning • Operational Execution & Launch • Supply Chain • Client/Vendor Relations • Risk Mitigation & Enforcement Crisis • Government Affairs & Policy Advocacy • Audit & Inspections • Health Authority Liaison • Portfolio Management & Lifecycle • Talent Acquisition & Organizational Restructure

Directed end-to-end regulatory, CMC, and clinical strategy for sterile injectables, ophthalmic, and respiratory BFS drug–device combination platforms and 503B outsourcing operations. Led IND, NDA, ANDA, 505(b)(2), and BLA submissions, achieving multiple first-cycle approvals and leveraging expedited FDA pathways • Partnered with R&D, Clinical, and Analytical Development to integrate design-control principles and human-factors data into product development, ensuring labeling, IFUs, and claims reflected clinical evidence, usability, and global standards • Supported development, shaping TPPs, formulations, delivery systems, and regulatory classification across pipeline and partner programs • Guided original and post-CRL submissions by aligning efficacy endpoints, study design, and clinical comparability for Phase 3 integration and PV readiness • Managed artwork, authored and maintained USPI, SPL listings, cartons, container labels • Directed CMC addressing sterility assurance, container-closure integrity, impurities, extractables/leachables, and expiration dating; led Mod 3 authoring and ICH Q12 lifecycle frameworks • Managed drug-shortage under Sections 506(c) and 506I, implementing risk based supply chain and plans enabling rapid approvals of critical therapies • Oversaw validation, and scale-up strategy across PPQ, aseptic process, filter integrity, and cleaning validation, as well as IQ/OQ/PQ equipment qualification Supervised analytical method development and validation (impurities, stability, dissolution) per ICH Q2 and USP standards, ensuring specificity, accuracy, precision, and linearity. Directed stability programs under ICH Q1A–Q1F supporting shelf-life extensions, comparability assessments, and global submissions • Led tech transfers and scale-up for new product introductions, ensuring process and SOP robustness • Served as primary FDA/DEA/BOP liaison, managing inspections, recalls, and CRL responses with consistent NAI/VAI outcomes

Served as Global Medical Device Lead, DDC & Sterile Injectable Lead, and Head of Consumer Health Directed filings across Biosimilars, NDAs, 505(b)(2), ANDAs, INDs, DMFs, EU MAAs, 510k’s, IVDs, CE Marking Technical Files/Design Dossiers Built ICH Q12 lifecycle strategies and PACMP frameworks overseeing CBE-0/PAS supplements, EU Variations (IA/IB/II), renewals, and annual reports to streamline change management and reduce RA burden. Implemented submission standards, analytical validation protocols, and impurity control strategies (ICH Q3A–Q3C, M7, USP 788/790), reducing review cycle times Directed eCTD submissions (Mod 1–5) including authoring, review, and lifecycle management, ensuring consistent global compliance and alignment across development programs. Supported product development integration through CMC oversight of formulation, scale-up, PPQ, and registration batches from preclinical through launch Led FDA Type A/B/C and Pre-Submission meetings, aligning on CMC, clinical, and labeling requirements. Guided harmonization for devices, drug–device combinations, and digital health, embedding ISO 13485, ISO 14971, and IEC 62304 for software-lifecycle compliance Chaired the Marketing & Advertising Review Committee, governing compliant Ad/Promo across Rx, OTC, and consumer brands. Built a FDA/FTC/NAD core labeling and claims substantiation framework for personal care products. Led Veeva-based labeling, artwork, and promotional workflows, embedding standardized review/approval across RA, QA, and Commercial to streamline compliance. Oversaw end-to-end labeling processes covering TLP, CCDS, USPI, and SmPC updates for new, supplemental, and mature products Managed 505(b)(2) Rx-to-OTC switch clinical design, human factors, self-selection, label comprehension, and user risk–benefit analysis, OTC monographs, supplements, cosmetics, and homeopathics Led due diligence and integration for acquisitions—from single products to large portfolios

• Achieved NSF Certified for Sport®, NSF GMP, and USP Verified certifications for supplements; implemented HACCP with 21 CFR 111 cGMPs and label claim testing protocols • Ensured 100% label claim compliance across drugs, supplements, and nutrition labeling via validated testing, controlled overages, and stability programs • Conducted comprehensive cGMP audits and unannounced inspections across all U.S. and U.K. fulfillment centers • Restored compliance following multiple FDA enforcement actions through governance systems for labeling, claims substantiation, and QMS improvements • Manage claims development process and support documentation for current products and new product development • Elected Member to Natural Products Association Board Competencies FDA/FTC labeling requirements: mandatory statements, net contents, nutrition/Supplement Facts formatting, disclaimers (21 CFR 101, 201). Ingredient verification: permitted substances, NDIs/ODIs, allergen and Prop 65 disclosures. Claims substantiation: structure/function mapping, clinical reference validation, risk language. Quality and safety checks: COA cross-verification, stability and identity tests, supplier documentation. Global compliance: import/export restrictions, foreign-market label variants, translations.

Directed enforcement actions, labeling compliance, and approval pathways within the Office of Compliance and Generic Drugs. Conducted undercover surveillance and operations to detect & remove products which posed a health hazard (directly or indirectly) to the public via deceptive & misleading advertisements per misbranding and new drugs provisions of the Federal Food, Drug, and Cosmetic Act. Coordinated enforcement actions with Field Offices including recalls, and seizures. Managed the review of Abbreviated New Drug Applications (ANDAs) across all dosage forms, amendments, supplements, suitability petitions, and all other document submissions from initial receipt to completion. • Determined completeness & acceptability of applications for filing; verified that submissions complied with all regulatory, scientific, & technical requirements. • Review focused on Modules 1-5; bioequivalence data (dissolution, pharmacokinetic, clinical endpoints, confidence intervals, area under the curve measurements); Chemistry Manufacturing & Controls (CMC) components & composition, batch formulations, specifications & tests, packaging, & stability; microbiology data; & Structured Product Labeling (SPL) in eCTD format. • Reviewed inactive ingredients, formulation, and Q1/Q2 controlled correspondence Served as Suitability Petitions Coordinator to facilitate review/approval under 21 CFR 314.93 for Reference Listed Drug (RLD) basis of submission changes to enable alternate dosage forms, strengths, or routes of administration while maintaining pharmaceutical equivalence and therapeutic substitution alignment. Served as Alternate Drug Shortage Coordinator and helped to develop proactive supply-chain continuity strategies under FD&C Act §§506C and 506I, supporting critical product prioritization, manufacturing notifications, and mitigation frameworks. PIV patent certification manager

Retired Lieutenant Commander in the Public Health Service (Health and Human Services, Office of the Surgeon General) Awarded; Four Outstanding Commendation Medals for national recognition & significance; Three Unit Commendation Medals – presented for a level of proficiency & dedication distinctly greater than that expected of the average officer; Two Crisis Response Service Awards - for critical interventions at geographical locations separate from duty stations (i.e. Hurricane Katrina); One Achievement Award – for career noteworthy contribution(s) toward the attainment of FDA Program objectives.