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Regulatory, Quality, Research and Development

Technical Affairs, Regulatory, Product Development Executive Management

Topic al S k i nc are S ol ut io ns, P erso na l C are, H air, P et C are, Pharm ac eutic a l (R x), OTC

Award-winning R&D and Regulatory leader and scientist dedicated to creating contemporary product solutions focused on innovation, market originality, and streamlined material allocation. By applying Six Sigma, Lean, and Agile methodologies, have transformed the research and development processes for every listed company and have saved an aggregate of $65+ MM over career tenure. Continuously pair client needs with compound development to combine the commercial with the scientific at the earliest stage of any product activity. Subject matter expert with regulatory and claim substantiation matters involving all the major US and large-market international agencies. As a well-known industry leader named in four patents, have conducted seminars and presentations on dermatological strategies, oral drug delivery, and project management innovation. Able to forge high-performing teams comprised of researchers and engineers generating notable brand name and private label products with revenues exceeding

$600 MM. Proven success in managing OTC and Rx conversions (Veterinary and Human products). Able to provide risk and toxicological assessments based on product development, domestic and global regulatory along with marketing analysis to determine best launch success.

SKILLS SUMMARY

FDA / EPA / EU / CN / JP / Health Canada Compliance • Capital Equipment and Purchasing Management • Continuous Improvement

•Cost Control • Greening of Products • Global Labeling Compliance • Claim Substantiation • Policy Development • Process Optimization • Product Development • Product P&L/Budgeting • Project Management • Quality Control/Quality Assurance • R&D Management • Regulatory Affairs • Safety • Staff Mentoring and Development • SWOT Analysis • Team Building • Fluency: Spanish, Italian, Portuguese – French and German (Reading and writing) • OSHA – SDS and 21 CFR 10.90 (FDA Gases)• OTC to Rx conversions • DMF, ANDA and NDA Preparations & Submissions • eCTD Submissions • In vitro Diagnostics and Simulations • 510K Submissions & Interpretations • Face to Face interaction with FDA, Health Canada and Mexico Departamento de Sanidad • GCP and GLP Practitioner and Experience • Toxicological Screens (In-Vitro and In-Vivo – EU/REACH, US/EPA & FDA, Health Canada, Anvisa/Mercosur and CFDA (China – In-Vivo methods) and Global OECD) • Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities • Claim Substantiation – Evidence Based / Statistical Analysis

Education and Affiliations

Ph.D. in Material Science and Engineering, New Jersey Institute of Technology, Newark, NJ

Dissertation title: New Screening Methodology for Selection of Polymeric Materials for Transdermal Drug Delivery Devices

Affiliations

National Honor Societies: Tau Beta Pi – Engineering nominated by Manhattan College Faculty Sigma Xi – Research - (nominated by Rutgers University Faculty)

Alpha Sigma Mu - Material Science and Engineering - (nominated by New Jersey Institute of Technology Faculty) Controlled Release Society, Member

Rheological Society, Member

American Association of Pharmaceutical Scientists (AAPS), Member New York Society of Cosmetic Scientists, Member

American Academy of Dermatology, Adjunct Member (Nominated by the Dermatology Faculty of Rutgers University - Inducted in December 2014)

LinkedIn page: https://www.linkedin.com/in/robert-falcone-0426915/

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Professional Experience Vantage Specialty Ingredients, Warren, NJ • 11/13 – Present

Global Compliance Manager – Personal and Pharmaceutical Care Ingredients - 1/15 – Present

2015 and 2016 Performance Impact:

-Help to launch 2 new skin topical ingredients in 2015.

-Completed GHS – SDS compliance ahead of schedule (2000 products / 8 languages).

-Invited by the CFDA to provide regulatory input on the new Hygienic Cosmetics Standards.

-Completed 42 REACH product submissions.

-Reduction of PPI by 43 % in 2015

-Reorganized / simplified HS Tariff Codes

-Successful completion of Certifications such as ISO, Ecocert, NJDA and NOP

-DMF Submissions – FDA and Health Canada

-ANDA Submissions – Proxy for Customers

-Rx to OTC Conversions Assistance provided to Customers – Proxy Representation

-In vitro Diagnostics and Simulations (Toxicology In-Silico)

-Face to Face interaction with FDA, Health Canada and Mexico Departamento de Sanidad (2 in 2017, 4 in 2016 – FDA and Health Canada)

-510K Submissions & Interpretations (1 in 2017 and 3 in 2016)

-GCP and GLP oversight and practice – 7 projects (internal and customers)

-In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

-In-Vivo (CFDA – limited)

-Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

-Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

Manage a group of 13 people involved in the following functions:

Quality (Control and Assurance) – 5 people – 2 QC and 2 QA (including a Manager) Global Regulatory – 4 (including a Group Leader)

Global Safety – 2

Global Technical Support – 2

Duties

Fully responsible for global strategic product initiatives involving product design, claims substantiation, regulatory compliance, quality by design, product testing (properties and claim substantiation).

-Fully responsible with interactions and collaboration with Regulatory and Advertising entities such as FDA, CFDA, EMA, Colipa, FTC, ASA, NAD among others

-Full professional interaction with professional societies and NGOs such as SCC / NYSCC, AAPS, AAD, Center for Dermal Research, EWG to mention few

-Fully responsible for implementing / maintaining ISO, Ecocert, National Organic Program, cGMP

-Fully responsible for global product stewardship – From idea to delivery

-Fully responsible for Safety, Toxicological and other related product evaluations

-ANDA Submissions – Proxy for Customers

-Rx to OTC Conversions Assistance provided to Customers – Proxy Representation

-NDA Submissions – Proxy for Customers

-In vitro Diagnostics and Simulations (Toxicology In-Silico)

-Face to Face interaction with FDA, Health Canada and Mexico Departamento de Sanidad (3 in 2015 – FDA) 510K Submissions & Interpretations (2 in 2015)

-GCP and GLP oversight and practice – 4 projects (internal and customers) – 2015

-In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

-In-Vivo (CFDA – limited)

-Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

-Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

Vantage Specialty Ingredients – Continued

Regulatory Manager – Personal and Pharmaceutical Care Ingredients - 11/13 – 1/15

2014 Performance Impact:

-Helped to launch 5 new products in 2014.

-Completed 37 products reviews for Mercosur in 2014.

-Began 53 REACH product evaluations.

-Achieved 19 Ecocert product approvals.

-Inducted as Adjunct member of the American Academy of Dermatology

-ANDA Submissions – Proxy for Customers

-Rx to OTC Conversions Assistance provided to Customers – Proxy Representation

-NDA Submissions – Proxy for Customers

-GCP and GLP oversight and practice – 5 projects (internal and customers) – 2014

-In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

-In-Vivo (CFDA – limited)

-Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

-Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

Managea group of 3 people involved in the following functions:

-Maintain and improve MSDS’s, labels and other related product safety information for 1,500 chemicals sold domestically and worldwide.

-Product compliance administrator (rule writing, specification and implementation

-Fully responsible for the creation and approval of consumer labels and claims.

-Participates in the team that performs new product evaluations for raw materials and formulations (Safety-In-Use, VOC, toxicity, health and safety, FDA and global submissions, etc.).

-Provides day–to-day regulatory support for new product development and commercialization.

-Register existing and new products to ensure commercial access into foreign markets such as EU, China and Mercosur.

-Coordinate and prepare document packages for submission to regulatory agencies, internal audits and inspections.

-Responsible to compliance questions or concerns from management as well as from customers.

-Provide customer support and interaction for regulatory questions and concerns.

-Continuously reviews product information to ensure all ingredients are in regulatory compliance in each country in which distribution of the company’s products is intended.

-Research and monitors changes in standards and regulations that may impact the company’s business.

-Provide product health and safety skills to internal and external stakeholders.

-Aid in the resolution of product health and safety issues.

-Responsible for joint development/implementation of Product Stewardship SOP’s.

-Participate in representing the Company at trade association meetings, advisory groups and related activities.

-Tracks, identifies, measures and communicates trends in regulatory transactions

-In vitro Diagnostics and Simulations (Toxicology In-Silico)

-Face to Face interaction with FDA, Health Canada and Mexico Departamento de Sanidad (2 in 2014 – FDA and Health Canada)

-510K Submissions & Interpretations (1 interpretation in 2014)

-In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

-In-Vivo (CFDA – limited)

-Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

-Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

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Peter Thomas Roth Labs, LLC, Carlstadt, NJ • 03/11 – 11/13

Research and development lab of progressive, cutting-edge skin care products for cosmetic and OTC industries

Director of R&D, Technical and Regulatory Affairs

Performance Impact: Developed and championed 13 bestselling skin care products with sell-through at QVC, Sephora, Ulta Beauty, and other cosmetic retailers. Earned five Good Housekeeping Seal of Approval awards. Have 10+ new personal care topical product concepts and formulas slated for 2013 distribution.

Created a skin care top seller for QVC. Sold more than 3K units’ opening night with retail price-point of $129.00. Company produced 60K units for QVC with sell-through in eight weeks.

Developed and tested skin care line for Sephora now adapted for Sephora India (60 products) and Sephora Brazil (40 products).

Leveraged testing and protocols for enhanced claim substantiation by using Health Canada, FTC, NAD rulings, FTC, COLIPA and CTFA / PCPC guidelines among others

Originated the product platform and design for four new skin lotion products launched in China. Developed in accordance with China-based regulatory requirements.

Reduced product development costs by 20% to 30% per product. Created and standardized a feasibility worksheet per new product development idea. Include Sales and Marketing at the initial stages of the product cycle. Eliminated redevelopment as product was matched to target audience and price points at the earliest of stages.

Established and maintained relationships with regulatory agencies, suppliers, academic partners, and customers. Planned and managed complex licensing requirements.

Labeling Compliance – (Pre, Launch and Post – FDA Cosmetic (UCM391202 & OTC Guidelines – Sunscreens, Acne to mention few), EU (EMA & EC Annex I, 1223 / 2009), Health Canada, China (CFDA), Brazil – Mercosur (ANVISA)).

ANDA Submissions

Rx to OTC Conversions Assistance

In vitro Diagnostics and Simulations (Toxicology In-Silico)

Face to Face interaction with FDA and Health Canada (5 – FDA and Health Canada)

510K Submissions & Interpretations (1 submission and 1 interpretation)

GCP and GLP oversight and practice – 8 projects

-In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

-In-Vivo (CFDA – limited)

Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

-Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

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US Nonwovens, Brentwood, NY • 10/09 – 3/11

Manufacturer of nonwoven fabrics for sanitary disposables, apparel interlining, filtration, acoustical wrappings

Director of R&D and Regulatory Affairs (FDA, EPA, Health Canada, EUDRA, JP)

Performance Impact: Redesigned R&D materials process with an inherent elegant simplicity. By “doing more with less,” enabled product development to manufacture economically 100+ MM units of nonwovens for private label sales ordered by Walmart, Target, Walgreens, and CVS. Focused on hemorrhoid, alcohol disinfecting, cosmetic removal, and general-use disinfection wipes. Conceptualized 10 new personal care product ideas and managed 20 new product development projects in personal and pet care.

Reduced R&D expenditure by $30 MM to $50 MM (20% to 40% reductions) by linking base material costs to product functionality and benefit-per-ingredient prior to development. New to company to bring in Sales and Marketing during product ideation process.

Collaborated with Marketing and Sales on the Client level. Incorporated client requirements at the earliest stages of R&D.

Developed new product platforms, product testing methodologies, innovative claim substantiation and experimentation protocols (from conception to the manufacturing phase).

Establish and maintain relationships with regulatory agencies, suppliers, academic partners, and customers. Plan and manage complex licensing requirements.

Labeling Compliance – (Pre, Launch and Post – FDA Cosmetic & OTC Guidelines, EPA, EU (EMA, REACH & EC Annex I, 1223 / 2009), Health Canada, China (CFDA), Brazil – Mercosur (ANVISA).

ANDA Submissions – Proxy for Customers

Rx to OTC Conversions Assistance

In vitro Diagnostics and Simulations (Toxicology In-Silico)

Face to Face interaction with FDA and Health Canada (3 – FDA and Health Canada)

510K Submissions & Interpretations (1 submission)

GCP and GLP oversight and practice – 6 projects (internal and customers)

In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

In-Vivo (CFDA – limited)

Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

Nice-Pak Products, Inc., Orangeburg, NY • 08/08 – 09/09

Manufacturer of pre-moistened wipes, i.e., baby wipes, antibacterial, lens cloths, cosmetic remover, surface cleaning

Director, Research and Development

Performance Impact: Honored with Outstanding Innovation Partner Awards from CVS, Target, and Walmart for green / sustainable products, including one product slated for the EPA’s Design for the Environment certification.

Saved $2.3 MM in initial R&D costs with overall projected savings of $8 MM by product’s end.

Led the development and commercialization of 40 new products within a year.

Labeling Compliance – (Pre, Launch and Post – FDA Cosmetic & OTC Guidelines, EPA, EU (EMA, REACH & EC Annex I, 1223 / 2009), Health Canada, China (CFDA), Brazil – Mercosur (ANVISA).

ANDA Submissions

Rx to OTC Conversions

In vitro Diagnostics and Simulations (Toxicology In-Silico)

Face to Face interaction with FDA and Health Canada (2 – FDA and Health Canada)

510K Submissions & Interpretations (2 submissions)

GCP and GLP oversight and practice – 7 projects (internal and customers)

In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

In-Vivo (CFDA – limited)

Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

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Church & Dwight Co., Inc., Princeton, NJ • 04/06 – 08/08

Manufacturer of sodium bicarbonate producing household cleaning, laundry, personal care, and pet care products

Program Manager, Transformation New Product Development

Performance Impact: Overhauled product development process generating $10 MM in savings by revamping supplier criteria, technology application, and product deliverables.

Launched 10 new products including two patent submissions yielding $15 MM in new revenues.

Patent focus on a new type of cat litter. Projected sales to reach $600 MM annually.

Products focused on both animal and human care, OTC, and pharmaceutical skin, hair, and household products. Directed new product development from concept to conclusion, supported product claims, and managed chemists, managers, and outside consultants.

GCP and GLP oversight and practice – 5 projects

Managed green platform for household, personal, and animal care products.

Establish and maintain relationships with regulatory agencies, suppliers, academic partners, and customers. Plan and manage complex licensing requirements. Labeling Compliance – (Pre, Launch and Post – FDA (UCM391202 & OTC Guidelines), EPA, EU (EMA & EC Annex I, 76 / 768), Health Canada, China (CFDA), Brazil – Mercosur (ANVISA). Veterinary and Human Use products.

Rx to OTC Conversions

In vitro Diagnostics and Simulations (Toxicology In-Silico)

Face to Face interaction with FDA and Health Canada (3 – FDA and Health Canada)

510K Submissions & Interpretations (2 submissions)

-In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

-In-Vivo (CFDA – limited)

-Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

-Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

Hartz Mountain Corporation, Bloomfield, NJ • 1/01 - 4/06

Manufacturer of consumer pet care products

Senior Scientist, Chemical Products Division

Performance Impact: Conceived and developed the first pet Breath Strips earning the “2005 Innovative Product of the Year” award from the American Pet Products Management and Packaging Associations.

Developed and launched approximately 50 new consumer pet products and facilitated the launch of 39 products through implementation of a new QA system.

Managed product development for animal OTC and pharmaceutical applications. Supervised product development, business alliances, and customer relations that included Walmart, Target, Petco, and Petsmart.

Led the development of new multivitamins, nutraceutical and functional ingredients.

Optimized market delivery strategy resulting in $25 MM in increased revenues, and implemented JIT methodologies for

$15 MM in annual savings.

Establish and maintain relationships with regulatory agencies, suppliers, academic partners, and customers. Plan and manage complex licensing requirements.

Labeling Compliance – (Pre, Launch and Post – FDA (UCM391202 & OTC Guidelines), EPA, EU (EMA & EC Annex I, 76 / 768), Health Canada, China (CFDA), Brazil – Mercosur (ANVISA). Veterinary and Human Use products.

GCP and GLP oversight and practice – 7 projects (internal and customers)

In vitro Diagnostics and Simulations (Toxicology In-Silico)

Face to Face interaction with FDA and Health Canada (7 – FDA and Health Canada)

510K Submissions & Interpretations (4 submissions)

GCP and GLP oversight and practice – 6 projects

In-Vitro Tox (OECD / REACH, EPA, Health Canada, Anvisa/Mercosur)

In-Vivo (CFDA – limited)

Risk Analysis / Assessments and defense reviews with domestic and global regulatory authorities

Claim Substantiation – Evidence Based / Statistical Analysis – ASTM, COLIPA, EMA and FDA methods

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Note on Toxicological tests used

Skin Sensitization Assays

Direct Peptide Reactivity Assay (DPRA) – In-Vitro - ECVAM approved – OECD

In Vitro Sensitization Screening Assay (IVSA) – In Vitro – Under ECVAM review

Human Cell Line Activation Test (h-CLAT) - In-Vitro

Ocular Assays

HET-CAM - Hen's Egg Test - Chorioallantoic Membrane

Bovine Corneal Opacity and Permeability Assay (BCOP)

Dermal Irritation Assays

3D Human Skin Equivalent Systems

Dermal Corrosivity Assays

MatTek EpiDerm™ Corrosivity Test

Phototoxicity Assays

3T3 mouse fibroblast cells – EC/COLIPA test

Cytotoxicity Assays

MatTek EpiDerm™

Mutagenecity Assays

Ames

ELISA testing

EPA (In Vivo / In Vitro tests)

870.1000 Acute toxicity testing-background

870.1100 Acute oral toxicity

870.1200 Acute dermal toxicity

870.1300 Acute inhalation toxicity

870.2400 Acute eye irritation

870.2500 Acute dermal irritation

870.2600 Skin sensitization

870.3050 Repeated dose 28-day oral toxicity study in rodents

870.3100 90-Day oral toxicity in rodents

870.3150 90-Day oral toxicity in nonrodent

870.3200 21/28-Day dermal toxicity

870.3250 90-Day dermal toxicity

870.3465 90-Day inhalation toxicity

870.3550 Reproduction/developmental toxicity screening test

870.3650 Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test

870.3700 Prenatal developmental toxicity study

To mention few. Done most of the 870 series as well as OECD.

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