Experience

HUVEPHARMA, INC

• United States
• Veterinary Services
• 100 - 200 Employee

• Senior Manager Regulatory Affairs

  • Jun 2020 - Present

• Senior Manager Regulatory Affairs

  • Jun 2020 - Present

• Pre-Approval Manager - Regulatory Affairs

  • May 2017 - Jun 2020

  Leader on pre-approval projects working collaboratively with internal and external stakeholdersDevelop regulatory strategy to align with business goalsWrite detailed technical reports, data reviews, and summariesWork with CROs to develop pre-approval study protocols and reports



Northeastern College of Professional Studies

• United States
• Higher Education
• 100 - 200 Employee

• Online Instructor

  • Apr 2011 - Jun 2020

  • Instruct online courses for Master of Science in Regulatory Affairs including New Drug Development, Introduction to Drug and Medical Device Regulations, Emerging Product Categories in the Regulation of Drugs and Biologics, and Food, Drug, and Medical Device Law • Instruct online courses for Master of Science in Regulatory Affairs including New Drug Development, Introduction to Drug and Medical Device Regulations, Emerging Product Categories in the Regulation of Drugs and Biologics, and Food, Drug, and Medical Device Law



Virbac

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager Regulatory Affairs

  • Nov 2012 - May 2017

  • Determine risk assessment and implement strategies for regulatory approvals for NADAs and ANADAs by providing input for product development and commercialization. Provides regulatory advice, strategy, and technical support to cross-functional teams including research and development and compliance. Collaborate with departments to identify opportunities for improvement and potential cost savings. • Manages direct reports. Leads junior regulatory affairs staff to identify development opportunities in accordance with department needs as well as employees’ individual career growth goals. o Manages team responsible for pre and post approval of veterinary feeds, supplements, grooming aids, and drug products for US and Canada. o Directs external regulatory consultants supporting the clinical team. • Lead meetings with FDA/CVM. Develops and maintains a positive working rapport with the governing regulatory agencies. • Participates in working and industry groups to provide input to help shape the regulatory landscape. • Monitor industry changes, trends, requirements, new product introductions, and market developments. Show less



Neos Therapeutics, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • May 2007 - Nov 2012

  • Represented Regulatory Affairs on cross-functional project teams. Provided regulatory strategies on all new products proposed by R&D, including OTC drugs, NDA/ANDA drugs, and dietary supplements. • Prepared and filed IND amendments and annual reports. Project lead for activities related to regulatory submissions, preparing submission packages and tracking information for annual reports. Prepared and coordinated reviews of new product applications, including writing CMC technical sections. • Served as primary regulatory lead for FDA audits. Supported external and internal cGMP audits. Prepared and timely filed responses to audit reports. Attended preNDA meetings with the FDA. Audited GLP facility and observed preclinical trial dosing. Observed clinical trial subject intake and dosing. • Lead in the labeling approval process, coordinating review of all labeling materials. • Researched and monitored regulations, laws, and guidance documents. • Drafted, reviewed, and approved SOPs, analytical protocols, specifications, validation documents, and annual product reviews from a regulatory perspective. • Directed DEA compliance efforts and served as the company liaison during DEA audits. • Ensured proper licensing and permitting of company for federal, state, and local agencies. Show less



Adecco Staffing at Adams Respiratory Therapeutics

• Fort Worth, TX

• Validation Specialist

  • May 2006 - May 2007

  • Wrote and executed protocols for equipment and process validations including protocol summary reports - compiling and reviewing data. • Composed and revised validation SOPs. • Audited completed protocols and reports to ensure all equipment and processes were validated. • Wrote and executed protocols for equipment and process validations including protocol summary reports - compiling and reviewing data. • Composed and revised validation SOPs. • Audited completed protocols and reports to ensure all equipment and processes were validated.



General Practice and Personal Injury Law Firms

• Dallas, TX

• Associate Attorney / Legal Assistant

  • Nov 2000 - May 2006

  • Performed legal research and case analysis. Prepared pleadings, discovery requests, discovery responses, correspondence, reports, and memos. Negotiated settlements for personal injury claims. • Consulted with potential and existing clients regarding cases. Coached clients and witnesses in preparation for depositions and hearings. Investigated claims by interviewing witnesses and police officers. • Maintained legal files and filing system, including client records and billing documents. Show less



Cardinal Health

• Fort Worth, TX

• Quality Assurance Engineer

  • Aug 2004 - Jun 2005

  • Investigated and prepared reports on the root cause of consumer complaints, deviations from procedures, results failures, and uncommon incidents during production. • Wrote/revised SOPs and Department Procedures. • Investigated and prepared reports on the root cause of consumer complaints, deviations from procedures, results failures, and uncommon incidents during production. • Wrote/revised SOPs and Department Procedures.



PepsiCo

• United States
• Food and Beverage Services
• 700 & Above Employee

• Microbiology Research Technician

  • Apr 1998 - Nov 2000

  • Tested food ingredients for microbial quality. • Verified food facility environmental samples for sanitation quality. • Trained new employees. • Tested food ingredients for microbial quality. • Verified food facility environmental samples for sanitation quality. • Trained new employees.



MYLAN PHARMACEUTICALS PRIVATE LIMITED

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Microbiologist

  • Sep 1993 - Oct 1997

  • Performed microbial limits test on raw materials and finished products, penicillin contamination tests, antimicrobial preservative tests, and antibiotic potency assays. Validated microbial methods. • Collected and tested environmental samples including air, potable water, and purified water. • Trained new microbiologists and assistants. • Prepared microbiological media, maintained laboratory culture collection, performed routine laboratory maintenance, and maintained instrument logbooks. Show less