Experience

Liggett Vector Brands

• Tobacco Manufacturing
• 200 - 300 Employee

• Vice President & General Counsel

  • Jan 2020 - 4 years

  Morrisville, North Carolina, United States After managing regulatory filings for Vector Tobacco, transitioned to Corporate Counsel role at affiliate Liggett Vector Brands during organizational restructuring, when advisement and influence of C-level leadership and corporate counsel became particularly integral as FDA regulations were imposed in 2009. As Vice President and General Counsel reporting to LVB president and indirectly to general counsel of parent company: ♦ Manage a multimillion-dollar legal budget, a hybrid team… Show more After managing regulatory filings for Vector Tobacco, transitioned to Corporate Counsel role at affiliate Liggett Vector Brands during organizational restructuring, when advisement and influence of C-level leadership and corporate counsel became particularly integral as FDA regulations were imposed in 2009. As Vice President and General Counsel reporting to LVB president and indirectly to general counsel of parent company: ♦ Manage a multimillion-dollar legal budget, a hybrid team of outside counsel, an internal attorney, two paralegals, and an administrative assistant ♦ Interpret and monitor complex and often ambiguous FDA regulations to ensure compliance, with deliverables ranging from routine filings to critical responses associated with business application requests ♦ Set, implement, and enforce corporate policies and procedures in an executive capacity to meet corporate objectives and commitments to shareholders ♦ Consult extensively with internal technical personnel and outside counsel to support, draft, and review response content comprising hundreds of pages of intensive background, scientific data, and exhibits ♦ Collaboratively support development of data, project, and records management systems and programs that include LIMS software, a document control system for FDA GMP requirements, and DocuSign capabilities

• Corporate Counsel

  • Jan 2004 - Dec 2019

  COMPLIANCE, GOVERNANCE, & INTELLECTUAL PROPERTY ♦ Led compliance efforts for LVB’s first e-cigarette and played a key leadership role on the product’s working group ♦ Conducted entity-level control testing to support Sarbanes-Oxley compliance ♦ Managed a portfolio of more than 500 domestic and foreign trademarks ♦ Implemented a SharePoint site to accessibly house critical business documents LIAISE, ADVISEMENT, & TEAM MANAGEMENT ♦ Monitored and advised government affairs… Show more COMPLIANCE, GOVERNANCE, & INTELLECTUAL PROPERTY ♦ Led compliance efforts for LVB’s first e-cigarette and played a key leadership role on the product’s working group ♦ Conducted entity-level control testing to support Sarbanes-Oxley compliance ♦ Managed a portfolio of more than 500 domestic and foreign trademarks ♦ Implemented a SharePoint site to accessibly house critical business documents LIAISE, ADVISEMENT, & TEAM MANAGEMENT ♦ Monitored and advised government affairs and senior leadership on legislation and agency regulations associated with the FDA’s new oversight of the tobacco industry ♦ Represented legal counsel on cross-functional teams to advise leadership on product regulatory requirements, FDA and FTC compliance, and MSA laws ♦ Liaised between outside counsel and C-level leadership on litigation matters ♦ Trained, managed, and supervised junior attorneys, paralegals, and administrative assistants FILINGS, RESPONSES, & CONTRACTS ♦ Prepared sire safety compliance certifications for all 50 states, Master Settlement Agreement certifications to 43 states, and state license and permit applications ♦ Submitted FDA Substantial Equivalence Reports, Ingredient Reports, Establishment Registration, and biannual updates in response to 2009 federal regulations ♦ Responded to FDA on-site inspections, collaborating with manufacturing personnel and outside counsel to collect and compile documentation that supported FDA requests ♦ Renewed and filed applications for more than 160 annual business license and permits ♦ Drafted, reviewed, and negotiated cross-functional and professional service contracts

• Regulatory Specialist – Vector Tobacco

  • Feb 2002 - Dec 2003

  SOPs & COLLABORATION ♦ Drafted and implemented SOPs for a tobacco product undergoing FDA clinical trial ♦ Monitored and reported on state and federal laws, regulations, and policy initiatives ♦ Provided regulatory advisement and assistance for research laboratory safety initiatives COMPLIANCE & REPORTING ♦ Supported international regulations associated with bioengineered seed, growth and harvest of bioengineered plants, new additive approvals, and cigarette sales domestically… Show more SOPs & COLLABORATION ♦ Drafted and implemented SOPs for a tobacco product undergoing FDA clinical trial ♦ Monitored and reported on state and federal laws, regulations, and policy initiatives ♦ Provided regulatory advisement and assistance for research laboratory safety initiatives COMPLIANCE & REPORTING ♦ Supported international regulations associated with bioengineered seed, growth and harvest of bioengineered plants, new additive approvals, and cigarette sales domestically and abroad ♦ Ensured regulatory compliance with USDA/APHIS regulations for bioengineered tobacco seeds, seedlings, and field plants ♦ Compiled and submitted state and federal reports on nicotine yields and product ♦ Produced annual reports for the FTC on product sales, advertising, and promotions



Pfizer

• Events Services
• 1 - 100 Employee

• Regulatory Affairs Intern - Animal Health Group

  • Jun 2000 - Apr 2001

  Exton, PA ♦ Transmitted periodic reports and promotional material for new animal drugs ♦ Assisted in submitting amendment to Supplemental New Animal Drug Application ♦ Researched and interpreted FDA, EPA, and USDA laws and applied them to promotional material and adverse drug reporting ♦ Communicated statutory information to the sales force through memorandums ♦ Briefed supervising attorney on various areas of pharmaceutical marketing ♦ Researched relevant case law regarding the… Show more ♦ Transmitted periodic reports and promotional material for new animal drugs ♦ Assisted in submitting amendment to Supplemental New Animal Drug Application ♦ Researched and interpreted FDA, EPA, and USDA laws and applied them to promotional material and adverse drug reporting ♦ Communicated statutory information to the sales force through memorandums ♦ Briefed supervising attorney on various areas of pharmaceutical marketing ♦ Researched relevant case law regarding the pharmaceutical industry Show less