OBJECTIVE:

• To obtain a rewarding position where my 19 years of experience in teh pharmaceutical / medical device quality assurance and regulatory affairs industry and background in chemistry will be valuable.

TECHNICAL SKILLS:

• Microsoft Windows
• Microsoft Office (Word, Excel, Power Point, Access, Outlook)
• Microsoft Visio
• Microsoft Project
• Adobe Acrobat Professional
• QuickBooks
• Proquis Enterprise
• QT9, Microsoft Certified Professional (MCP)
• Regulatory Affairs Professional Society (RAPS) Member

PROFESSIONAL EXPERIENCE:

Confidential, Dania Beach, FL

Regulatory Affairs Manager

Responsibilities:

• Responsible for teh authoring and assembling United States (US) Food And Drug Administration (FDA) 510(k), European Union (EU) Technical Files, and international dossiers (Health Canada, Australia, New Zealand, Korea) for all Class II active and Class I medical devices: plan, collect, and review relevant information from other departments, write teh application and direct staff on assembling components of teh application.
• Point of contact on regulatory submissions, resolve issues/ inquires/ additional information requests and follow up to ensure submissions were acceptable for filing and/or approvable.
• Regulatory Assessment of design changes
• Researched and documented global regulatory requirements
• Support product development, product management, project management and quality assurance teams in coordinating and preparing pre - marketing and related product packaging to support optimal timelines for product launches
• Created and revised product instructions for use/labeling per current regulatory requirements
• Generate and revise quality system procedures per current regulatory requirements.
• Proofread, approved and updated labeling/literature/marketing materials in electronic documentation system
• Responsible for proper handling of all product safety related complaints and any required regulatory notifications
• Lead Field Corrective Actions such as Recalls, Field Safety Alerts, Market Wifdraws and Stock Recovery upon plan approval
• Supervised one Regulatory Affairs Specialist

Confidential, Fisher Island, FL

Senior Manager Regulatory Affairs and Quality Assurance

Responsibilities:

• Develop, implement, and maintain all aspects of an effective quality management system that meets teh requirements of teh Food and Drug Administration (FDA) and all other applicable standards
• Serve as Management Representative to oversee and report on teh effectiveness of teh quality management system to executive management, report on improvements needed, and ensure awareness of regulatory and customer requirements throughout teh company
• Ensure that products are designed, developed, and manufactured in accordance wif internal procedures and meet teh requirements set forth in teh application regulations and standards
• Direct internal audits to monitor teh effectiveness of teh quality management systems
• Develop and monitor compliance wif quality agreements wif suppliers and contract manufacturers; conduct supplier selection and annual audits of suppliers and contract manufacturers
• Act as primary liaison wif regulatory agencies and certifying bodies for all regulatory submissions, responses to inquiries, site inspections and all matters regarding compliance wif quality system requirements and product complaints/problems
• Prepared and filed responses to FDA warning letters and Establishment Inspection Reports (EIR) observations.
• Maintain FDA 510(k) regulatory submissions
• Regulatory Assessment of design changes
• Development and implementation of regulatory strategies based on US regulations, and guidance
• Coordinate teh review of product labeling and advertising
• Establish and implement company-wide documentation procedures used in fulfilling Quality System Regulation (QSR) requirements
• Establish regular employee in QSR regulations
• Responsible for all Medical Device Reporting (MDR) reporting to US FDA
• Proactively champion quality assurance issues where applicable in company-wide activities
• Plan, schedule, and complete projects in a manner consistent wif company objectives
• Regularly make presentations to teh management as required regarding project status
• Proactively communicate project status to management
• Supervised one Regulatory Affairs and Quality Assurance Associate

Confidential, Lauderdale, FL

Senior Manager, International

Responsibilities:

• Project Management
• Planned, executed, and finalized International Projects according to strict deadlines from registration through commercialization and revises as appropriate to meet changing needs and requirements.
• Identified resources needed and assigned individual responsibilities to three International Project Specialists
• Managed day-to-day operational aspects of a project and scope and factory / client interactions including setting and managing expectations
• Tracked and reported team projects timelines on a weekly basis to ensure project documents are complete, current and stored appropriately
• Product Management
• Development, implementation, formulation, execution of international strategic marketing strategies for teh BGM product portfolio and strategy including:
• Market Analysis & Strategic Planning: Identified market growth opportunities and developed business plan. Drove new business and opportunities.
• Managed Product Portfolio: Product positioning and lifecycle management
• Packaging / Messaging Development
• Trade Show Support
• Liaison between internal departments and international sister offices: Regulatory Department, Research and Development, Operations, Supply Chain, Customer Service, Customer Care
• Identified business development and add-on sales opportunities as they relate to specific projects
• Facilitated client and team meetings
• Conducted project post mortems and create a recommendations report in order to identify successful and unsuccessful project elements
• Development and management of budget (expenses) for international
• Proofread and approved international labeling/literature/marketing materials in electronic documentation system.
• Supervised three International Project Specialists

Confidential

International Regulatory Affairs Supervisor

Responsibilities:

• Prepared, reviewed, submitted, and maintained international registration dossiers (European Union, Canada, LATAM, Australia, Azerbaijan, Bangladesh, Cambodia, China, India, Iraq, Iran, Japan, Kazakhstan, Laos, Malaysia, Myanmar, Pakistan, Philippines, Saudi Arabia, South Africa, Russia, Singapore, Taiwan, Thailand, Turkey, Vietnam) for Class II In Vitro Diagnostics and Class I Medical Devices.
• Prepared, reviewed, submitted, and maintained USA FDA 510(k) Submissions as needed
• Reviewed laboratory and clinical validations for compliance prior to inclusion in submissions
• Researched and documented global regulatory requirements
• Provided independent regulatory leadership to international marketing team in coordinating and preparing pre-marketing and related product packaging to support optimal timelines for product launches
• Created and revised product instructions for use/labeling per current regulatory requirements
• Coordinated translation of product labeling and literature into foreign languages.
• For international dossiers, requested s of foreign government (CFG) and notary s from teh secretary of state and/or consulate.
• Generate and revise quality system procedures per current regulatory requirements.
• Proofread, entered, approved and updated labeling/literature/marketing materials in electronic documentation system
• Provided regulatory advice and counsel to various departments and customers
• Quality System Internal Auditing
• Supervised two Regulatory Affairs Specialist II and one Regulatory Affairs Analyst I

Regulatory Affairs Consultant

Confidential, Orlando, FL

Responsibilities:

• Responsible for teh authoring and assembling INDs, IDEs, ANDAs, and regulatory submissions amendments, supplements, and international dossiers for pharmaceuticals and for medical device clients.
• Reviewed chemistry, microbiological, and process validations for compliance prior to inclusion in submissions.
• Reviewed submissions to ensure that regulatory submissions are complete, properly formatted, and complied wif applicable regulatory requirements before submitting to clients for review to ensure timely submission.
• Prepared and filed responses to FDA warning letters and EIR observations.
• Act as a point of contact on regulatory applications, resolve issues/ inquires/ deficiency letters and follow up to ensure submissions were acceptable for filing and/or approvable.
• Interacted wif regulatory bodies regarding inquiries, submissions, and during inspections.
• Maintained client facility and product registrations, domestic and foreign.
• Identified, contracted, and managed outside consultants/ contractors for analytical method development / validation pertaining to a deficiency response.
• Generated and revised Good Manufacturing Practice (GMP) and quality system procedures and product labeling per current regulatory requirements.
• Applied regulatory noledge and experience to advise clients on drug and medical device development program strategies to ensure acceptance and earliest possible approval of submissions.
• Quality System Auditing.

Confidential, Orlando, FL

Regulatory Affairs Manager

Responsibilities:

• Responsible for teh authoring and assembling INDs, IDEs, ANDAs, and regulatory submissions amendments, supplements, and international dossiers (Europe, Health Canada, LATAM) for generic oral inhalation solutions and medical devices: plan, collect, and review relevant information from other departments, write teh application and direct staff on assembling components of teh application.
• Reviewed chemistry, microbiological, and process validations for compliance prior to inclusion in submissions.
• Reviewed submissions to ensure that regulatory submissions are complete, properly formatted, and complied wif applicable regulatory requirements before submitting to management for review to ensure timely submission.
• For international dossiers, requested free sale s, s of pharmaceutical product, and notary s from teh secretary of state and/or consulate.
• Prepared and filed both quarterly and annual periodic adverse drug experience reports.
• Prepared and filed response to FDA warning letters and Establishment Inspection Reports (EIR) observations.
• Act as a point of contact on regulatory applications, resolve issues/ inquires/ deficiency letters and follow up to ensure submissions were acceptable for filing and/or approvable.
• Interacted wif regulatory bodies regarding inquiries, submissions, and during inspections.
• Maintained facility and product registrations, domestic and foreign.
• Identified, contracted, and managed outside consultants/ contractors for analytical method development / validation pertaining to a deficiency response.
• Maintained document control system of teh regulatory department including maintenance of archive systems, both paper and electronic.
• Generated and revised GMP and quality system procedures and product labeling per current regulatory requirements.
• Participated and supported new product and/or process developments by providing independent regulatory leadership to development teams (internal and external) in coordinating and preparing pre-marketing and related submissions to support optimal timelines for product launches.
• Established development and implementation schedules and monitored projects through to completion wif all levels of internal organization.
• Identified, contracted, and managed outside consultants/contractors for deformulation studies and analytical method development/ validation resources.
• Identification of active pharmaceutical ingredient (API) manufacturers and suppliers. Requested samples of APIs, technical package, and EIR. Submitted samples to teh chemistry and microbiology departments for API vendor qualification. Developed and maintained noledge of teh history and manufacture of APIs and critical components.
• Applied regulatory noledge and experience to advise management on drug development program strategies to ensure acceptance and earliest possible approval of applications and submissions.
• Provided regulatory advice and counsel to various departments and customers.
• Maintained subscriptions and reviewed technical publications, articles and abstracts to stay abreast of technical developments in teh industry.
• Quality System Internal Auditing.
• Supervised three Regulatory Affairs Analysts.

Confidential, Lake Buena Vista, FL

Analysis

Responsibilities:

• Analysis of wastewater, surface water, ground water, and compost/sludge samples according to EPA standard methods and quality assurance protocol.
• Proficient and noledgeable in teh areas of wet chemistry (total dissolved solids, total suspended solids, total alkalinity, total volatile solids, nitric acid-hydrochloric acid liquid metals digestion, mercury digestion, microwave digestion, Carbonaceous Biochemical Oxygen Demand (CBOD), Biochemical Oxygen Demand (BOD), Chemical Oxygen Demand (COD), oil and grease, semi-micro-Total Kjedahl Nitrogen (TKN), Total Organic Carbon (TOC)) and instrumentation (Lachat Flow Injection AutoAnalyzer, Dionex Ion Chromatograph (IC), Metrohm Autotitrator, P.S. Analytical Limited Mercury Analyzer, Perkin Elmer Sciex Elan 5000 ICP-MSA).

Confidential, Orlando, FL

Laboratory Assistant

Responsibilities:

• Prepared solutions and equipment for research and teaching laboratories
• Implemented and enforced laboratory safety and hazardous materials management programs.
• Assisted in teh conversion to computerized inventory.

Confidential, Orlando, FL

Research Assistant

Responsibilities:

• Developed teh optimum conditions for teh yield and product selectivity of chemical intermediates and target compounds for teh oxidation of a primary amine wif benzoyl peroxide.
• Use of modern chromatographic (flash, TLC, HPLC) and spectroscopic (IR, NMR, MS) techniques for purification and structural identification.
• Application of modern computational chemistry techniques for teh determination of potential energy surface and molecular design.