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Click here or scroll down to respond to this candidateCandidate's Name , BS, MS, MBARegulatory Affairs Professional7 Spring Meadow Drive, Ewing, NJ Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLESUMMARYRegulatory Affairs Leader with 19 years of experience in FDA, EPA and CPSC regulations. Provided regulatory strategy for clearance of Medical Devices and approval of Prior Approval Supplement (PAS), and EPA products. Skilled in Personal Care, Home Care products, OTC monograph drug products, their regulations and labeling.Worked with the Flavor and Fragrance teams on Global, US Federal and States regulations pertaining to Flavors and Fragrances.Knowledgeable in California Cleaning Products Right to Know Act, California (SB312) The NY Department of Environmental Conservations (DEC) Cleansing Product Information Disclosure Program, California Safe Cosmetic Reporting, States regulation on Chemicals of High Concern in Childrens Products, Voluntary Cosmetic Reporting (VCRP) and Hazardous labeling for HC products regulated by CPSC. Track and Monitor Post Consumer Resin (PCR) and Extended Producer Responsibility (EPR) legislations (Domestic and International).WORK EXPERIENCEPrincipal Regulatory Affairs Specialist/Manager Regulatory AffairsCHURCH & DWIGHT CO. INC., Ewing, NJ 2020-2023Provide U.S. Regulatory expertise and direction in support of brands (Consumer Goods Products for Personal Care, Home Care and OTC products) from concept to launch. Develop strategy on complex technical projects. Strategy includes liaising between company and domestic regulatory authorities (e.g. FDA, EPA, CPSC), providing feedback on potential new products.Supporting acquisition actions including assisting management in due diligence review, and leading development of any training required in on-boarding activities for new employees. Analyze emerging technologies with R&D and support the consumer research group with study design in all brand areas. Provide technical mentorship to junior team members. Serve as a lead technical interface for the department.Collect and analyze data in support of regulatory submissions, draw conclusions, and make data-based recommendations to management or brand/R&D teams on regulatory pathways.Support various product studies and consumer/clinical studies to gain critical consumer insights for product development and/or to gather/evaluate data in submission activities.Manager Regulatory AffairsCOLGATE-PALMOLIVE CO., Piscataway, NJ. 2013 to 2020Responsible for Regulatory and Compliance guidance, strategy and support on projects for Personal Care (pc), Oral Care (OC), Home Care (HC), and Industrial products to deliver continuous pipelines of new products and line extensions to sustain growth. Led the review of Clinical and Home Use Tests protocols, Products ingredients list, Glossary of ingredients for PC and HC products and marketing product (labels/artwork). Collaborated with cross-functional teams (Legal, Marketing, Clinical, Product Development, Implementation and Support) to deliberate, review and assess claims for packaging and advertising for all categories. Trained, managed and mentored Regulatory Affairs Specialists on regulations for cosmetics, claims, label review and approval. Primary regulatory contact for specific projects and programs.Successfully launched pipelines of Personal Care Products under these brands Irish Spring (body wash, bar soap, deodorants, antiperspirants), Softsoap (body washes, antibacterial and non-antibacterial liquid hand soaps), Mennen (mens and womens antiperspirants/deodorants), Protex (bar soaps and liquid hand soaps) and Palmolive (bar soaps).Successfully filed and received clearance for Colgates first dry mouth medical device Hydris Dry Mouth Oral Rinse with CDRH.Led and performed Regulatory Assessment process for concepts, product ingredients and claims.Trained Product Development and Quality personnel on regulatory requirements for INDs, 510(k), NDA, and related supplements, and supervised and trained interns on US FDA and EPA regulations.Reviewed and approved all labeling, ingredients list for Oral Care, Personal Care, Home Care and Industrial products.Participated in Trade Associations and professional society activities such as American Cleaning Institute (ACI), Drug Information Association (DIA), Personal Care Product Council (PCPC), and EPA Antimicrobial Work Group.Monitored regulatory websites FDA, EPA, Consumer Product Safety Commission (CPSC), States, for new guidances and/or activities that might impact current and future internal or external projects.Created Regulatory Alerts (RA) on issues that impacted Colgates products and shared the RA with Senior Management and other Stakeholders.Successfully filed Investigational New Drug (IND) applications, IND annual reports.Senior Regulatory AffairsCOLGATE-PALMOLIVE CO., Piscataway, NJ. 2009 to 2013Provided regulatory leadership in strategic planning and execution of submissions, applications and other regulatory documents to EPA, FDA, Federal Regulatory agencies and States regulatory agencies. Ensured compliance with all applicable guidance, regulations and laws for Oral Care, Personal Care, Home Care and Industrial marketed products. Provided Regulatory solutions to senior management and other key business partners by making a case with clear documentation. Influenced definitions and standards for regulatory requirements. Worked with cross functional teams to create a climate of teamwork within the organization, focusing on the synergies among functions. Interfaced with internal/external legal counsel, company consultants and business development on various regulatory issues associated with projects under development.Successfully registered Colgates first antimicrobial dish detergent with the EPA and in the 50 States, DC and US Territories.Provided regulatory guidance and support that resulted in the successful US launch of Colgates first acne bodywash, Colgates first antidandruff shampoo, and toothpastes Colgate Sensitive Pro-Relief, Colgate Optic White and Colgate Enamel Health.Granted You Can Make a Difference award for strategic regulatory guidance for EPA registration of Colgates first Palmolive antibacterial dish liquid.Reached consensus with key business partners including Corporate Technology on product regulatory goals and timetables, as well as other important priorities.Negotiated expectations and agreements with key internal/external business partner by leveraging regulatory expertise, business knowledge and record of prior success.Arranged, prepared and attended face to face EPA meeting regarding regulatory pathway, the Agencys position on issues and pre-submission application.Senior Regulatory Affairs SpecialistCOLGATE-PALMOLIVE CO., Piscataway, NJ. 2005 to 2009Built strong relationship among all operating stakeholders including Legal, Marketing, and Product Development from all categories to bridge understanding of each others roles, strategies and priorities.Arranged and contacted EPA and FDA for meetings and teleconferences to discuss pre-submission and post-submission requirements.Monitored pertinent Federal regulatory websites FDA, EPA, Consumer Product Safety Commission (CPSC), for new guidance or activities that might impact current and future internal or external projects.Prepared responses to EPA and FDA questions and correspondence for submissions and registered products.Reviewed and approved product labels for EPA regulated products (Pesticides), OTC Drug products, Cosmetics products and Industrial cleaning products.Created, reviewed and revised Standard Operating Procedures as needed.Reviewed and approved protocols and informed consents for clinical, panel and consumer studies.Reviewed and approved product formulae for toothpastes, antiperspirants, bar soaps, liquid hand soaps, body washes, dish detergents, sanitizers, disinfectants, all-purpose cleaners, antibacterial hand soaps for national launch.Led Colgates effort in the Soap and Detergent Association (SDA) and Consumer Specialty Products Association (CSPA) ingredient communication initiative to inform consumers about product ingredients.Colgates representative to the ACI Environmental Preferred Product (Bio-based) Task Force.Led Colgates North America Regulatory Affairs efforts on sustainability and provided quarterly reports to the Global Task force.Regulatory Affairs & Marketing ManagerPIC Corporation, Linden, NJ. - 1998 to 2005Responsible for regulatory compliance issues associated with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Coordination and monitoring of data generated for registration and registration of end-use products within budget, including product chemistry, toxicity, efficacy, residue chemistry and ecological effects. Managed seven (7) personnel on all regulatory and technical services to customers, internal sales, private registration firms, marketing groups and other agencies. Responsible for the investigations and response to all customer complaints and matters pertaining to product usage.Liaised with US EPA, FDA, and State Regulatory Agencies, Health Canada and International Regulatory Organizations.Purchased chemicals and related raw materials used in the manufacturing of new and existing products.Managed new product labeling submitted to EPA and FDA for product registration.Responsible for product registration and maintenance of 50 PIC products and sub-registrations of 30 private labeled products with EPA and PDA.Prepared and submitted annual reports with EPA for domestic and international pesticide producing establishments.Registered pesticide products in Brazil, Canada, Estonia, France, Ghana, Great Britain, Korea and Malta.Liaised and interacted with manufacturers/vendors in Asia, South America and Europe that accounted for over 80% of products sold.Developed and managed formulations for insect control products that generated over $700,000 in sales in the first year.Managed marketing plans for topical analgesic Over-the-Counter (OTC) drug products.EDUCATIONMBA in International BusinessRutgers University Graduate School of Management, NJ. 1996MS ScienceUniversity of London Imperial College of Science & Technology. 1985BS in AgricultureUniversity of Sierra Leone Njala University College. 1982SKILLSFDA Regulations.cGMP.GLP.APIsMicrosoft OfficeEPA Regulations.Computer LiteracyConsumer Product Safety Commission (CPSC) Regulations.California Safe Cosmetic Reporting.CA Right to Know Regulations (CA RTK).Voluntary Cosmetic Reporting Program (VCRP).Chemicals of High Concern in Children's Products ReportingOTC Drug Products Labeling.Artwork/Label review for Oral Care, Personal Care, Home Care and Industrial products.Registration of Products in the US and outside of the US.Review of protocols for Clinical, Consumer and Home Use Test studies.Medical Device submission - 510(k), PMA.IND and PAS submissions.NY DEC Cleansing Product Information Disclosures.Hazardous labeling for Home Care Products.Cosmetic Products Labeling |
