Profile

Experienced Regulatory Affairs Management Professional with extensive experience and knowledge supporting business operations related to State and Federal Regulatory Affairs Compliance.

• Specialist in compliance regulations related to Drug Enforcement Agency, State Boards of Pharmacy, Alcohol, Tobacco, Firearms and Explosives, Tax and Trade Bureau, and the FDA including PDMA procedures.
• Facilitated company implementation of new regulations and rule changes approved by all State Boards of Pharmacy throughout the United States.
• Liaison/diplomat with Federal and State Agency regulatory management communications.
• Coordinated and managed TTB Operating Permits, DEA Registrations, State Board of Pharmacy Permits, applications and documents required by the National Association of Boards of Pharmacy for Verified Accredited Wholesale Distribution of Pharmaceuticals required by state regulations.
• Performed and submitted required DEA, TTB, State Boards of Pharmacy internal audits and individual monthly state compliance reporting related to chemicals and pharmaceuticals.
• Evaluated federal and state agency site inspections and facilitated corrective action if required.

Professional Experience

Confidential

Senior Manager Regulatory Affairs Specialist III 2010 to 2012

• Lead Internal Auditor responsible for the management and internal audit process throughout the company distribution and production facilities. Lead and schedule a team of auditors who evaluate and perform site audits of warehouse, laboratory and distribution facilities to ensure compliance with cGMP, National Association of Board of Pharmacy Certifications and ISO 9001:2008 as well as processes associated with state and federal agencies. Assess final audit with management personnel responsible for facility and review best practices, observations and findings. Develop action plans to correct observations in a timely manner. Review and rewrite company Standard Operating Procedures and ensure employee compliance. Interact with regulatory agencies during audits and inspections.
• Sustained regulatory compliance and policies by reviewing company logistics and obtain and maintain licenses and permits as required by federal and individual state agencies.
• Researched and interpreted government rulings on regulation and compliance changes ensuring seamless operations and facilitating corrective and proactive compliance action.
• Supported Warehouse compliance activities and trained personnel on regulations concerning, Drug Enforcement Agency, State Boards of Pharmacy, Alcohol, Chemical and Explosive Materials.
• Trained on various transportation, chemical and pharmaceutical procedures including DEA, FDA, TTB, DOT, IATA, SARA, ITAR, radioactive and etiologic materials, National Association of Boards of Pharmacy, Chemical Risk Management Program (RMP), Community Right-To-Know (EPCRA) and The Department of Homeland Security.
• Educated internal and external customers regarding federal, state and local laws and regulations.
• Perform Risk Management Evaluations and reported results to Federal, State and local jurisdictions.

Confidential. Philadelphia, PA 2009 to 2010

Supervisor, Chemical/Pharmaceutical Operations-P.E.T.

• Manages, coordinates and evaluates the daily activities of technical and production staff producing radioactive pharmaceuticals injected into patients prior to P.E.T. scans.
• Manages Quality Control Supervisor and Radiation Safety Officer and assists and evaluates daily, biweekly and monthly internal audits performed by each unit.
• Responsible for Change and Preventative Action plans and requirements
• Organize, implement and maintain a control system for generation and revision of cGMP and Pharm , CFR 210/211/212 and related documents including Batch Records, SOPs, Change Controls, Investigations, Quality and Standard Forms.
• Manage production batch records and product release process.
• Sets team priorities and ensures task completion while coordinating work activities with other supervisors.
• Works within budgetary/financial objectives set by VP Cardinal Health Operations.
• Resolves day-to-day and non routine problems using defined business processes.
• Participate with company audits/inspections conducted by internal or by government agencies.
• Provide monthly reports and other routine correspondence to Director and Corporate Officers.
• Responsible for maintaining, coordinating and documenting a preventative maintenance program of laboratory equipment and building equipment and schedules repairs as necessary.
• Schedules or performs required monthly, quarterly and annual laboratory equipment calibrations and standardizations.
• Authorized User Certification-Cyclotron

Confidential., West Chester, PA 1996 to 2008
VWR International distributes more than 1,500,000 different laboratory products. These goods range from chemicals, pharmaceuticals, lab instruments to protective clothing.

Senior Manager Regulatory Affairs Analyst 2002 to 2008

• Sustained regulatory compliance and policies by obtaining and maintaining approximately 150 licenses and permits as required by federal and individual state agencies.
• Researched and interpreted government rulings on regulation and compliance changes ensuring seamless operations and facilitating corrective and proactive compliance action.
• Supported Warehouse compliance activities and trained personnel on regulations concerning, Drug Enforcement Agency, State Boards of Pharmacy, Alcohol, Chemical and Explosive Materials.
• Updated changes related to Standard Operating Procedures for 22 warehouses relating to new or changing State or Federal regulations in a timely manner for throughout the United States and Puerto Rico.
• Trained on various transportation, chemical and pharmaceutical procedures including DEA, FDA, ATF, DOT, IATA, SARA, ITAR, radioactive and etiologic materials, National Association of Boards of Pharmacy, Chemical Risk Management Program (RMP), Community Right-To-Know (EPCRA) and The Department of Homeland Security.
• Educated internal and external customers regarding federal, state and local laws and regulations.
• Perform Risk Management Evaluations and reported results to Federal, State and local jurisdictions.
• Provided advice and guidance to VWR departments engaged in projects related to chemicals, pharmaceuticals and medical devices.
• Managed and trained a team to support regulatory affairs compliance requirements.
• Responded to subpoenas and depositions and appeared in court proceedings as expert witness related to the production of illegal drugs and associated activities.

Buyer III/Purchasing Representative 1999 to 2002

• Managed $100 million dollar national purchasing portfolio.
• Negotiated pricing for third party orders for merchandise not in company inventory.
• Processed marketing and stocking requests from sales force. Replenished chemical and pharmaceutical inventory, expedited orders, resolved price discrepancies, and managed vendor portfolio for 16 warehouses and 23 consignment facilities throughout the United States and Canada.
• Acquired inventory for warehouse activity and provided technical management of suppliers and lead process improvements.

Sales and Customer Service 1996 to 1999

• Managed accounts and implemented strategies to support and optimize territory growth.
• Prepared quotes, processed sales orders, and employed outstanding follow-up practices.
• Interact with customer base to assure satisfactory quality service.
• Resolve all issues involving discrepancies with freight shipments or invoices.
• Promote and recommend replacement product for orders with extended back order delivery dates.
• Investigate and resolve delivery issues involving lost, damaged misplaced customer orders.

Education

BS Degree in Chemistry
Regulatory Affairs in a Technical Environment,
Six Sigma Green Belt
cGMP for the Warehouse Certificate

Career Training and Development
Drug Enforcement Agency Chemical Industry Conference September 2008
Drug Enforcement Agency Pharmaceutical Industry Conference September 2007
Drug Enforcement Agency Chemical Industry Conference November 2006
Drug Enforcement Agency Pharmaceutical Seminar April 2005
Pharmaceutical Pedigree Requirements in the United States Stovall Consulting March 2007
EPCRA Compliance Seminar ABS Consulting June 2007
Focusing on the ITAR Seminar OCR Services June 2007
Essentials of Business Development Certificate Regis University December 2006
Excelling as a First-Time Manager or Supervisor Skill Path Seminars June 2007
Complying with EPA's RMP Rule (40 CFR 68) Submitting, Updating and Resubmitting Risk Management Plans ABS Consulting September 2008.
Responsible Management Christie and Associates May 2010
Managing Effective CAPA Projects Workshop Master Control April 2011
14th Annual Controlled Substance, PMDA and State Conference June 2011 Cegedim Management