Consulting Firm 2020 ‐ present
Responsible for providing companies of all sizes with regulatory affairs assistance specializing in biologics, advanced therapy medicinal products, pharmaceuticals, medical devices and combination products on the global level. Responsibilities include development of regulatory strategy to support optimal progress of projects from product development through to initial approval as well as geographical roll‐out and post‐market compliance activities. Additional responsibilities include strategic development for orphan/rare disease therapies and expedited/accelerated pathways; leading teams in the preparation and execution of key interactions with Health Authorities worldwide; review of key regulatory documents to support all regulatory submissions throughout a product’s lifecycle; due diligence activities for products (both in development and marketed) and whole company assessment; and regulatory intelligence. Customizes and holds training sessions in areas such as history of regulation(s), product development and post‐market compliance.
Galderma Research & Development, LLC, Fort Worth, Texas 2017 – 2020
Responsible for planning, managing and performing all regulatory activities to support prescription products worldwide. Assure optimal progress of prescription product development projects from pre‐ IND / CTA stage to NDA/BLA/MAA approval. Key responsibilities include leading teams in all interactions with Health Authorities (e.g. FDA, EMA, Health Canada); designing, implementing and maintaining global regulatory and development strategy; directing and providing regulatory support and expertise to the prescription research and development teams; leading all activities in the preparation/review of key regulatory documents and following evolution of regulations, anticipating impact on long‐term regulatory and development activities.
Responsible for building the Global Regulatory Affairs function within the Prescription Strategic Innovation Group which included organizational design, development of key roles, recruitment and on‐ boarding activities. Developed and streamlined processes to align with strategic direction for new organization. Responsible for management of global regulatory affairs project management, market support management (including maintenance and renewal activities), regulatory CMC management, regulatory operations (including publishing, RIMS, archiving, regulatory intelligence) and scientific writing.
Serves as member of Prescription Strategic Innovation Group Executive Leadership Team as well as key Pipeline, Operational and Strategic Councils providing regulatory strategy and direction. Also, provides due diligence for potential product / company acquisitions and licensures. Responsible for departmental operating budget >5 million.
Smith & Nephew Inc. / Healthpoint, Ltd., Fort Worth, Texas 2003 ‐ 2016
Managed global regulatory affairs function across Advanced Wound Management (AWM) with teams in the United States, United Kingdom and Japan. Key responsibilities included interaction with regulatory agencies / bodies to ensure review and approval of development plans and timely resolution of issues, oversight of dossier compilation and approval [IND, BLA, CTA, NDS, MAA, IDE and 510(k)], strategy for major manufacturing transfer projects, general product life cycle management (pre‐ and post‐market activities) and regulatory intelligence. Defined strategy, initiated activities, received approval for removal of Boxed Warning from labeling for biologic product.
Built, developed and led the Regulatory Affairs function to support the evolving needs of the organization from start‐up capability to leading worldwide organizational change.
Served as member of Advanced Wound Management Executive Leadership Team with responsibility for the development of both business and strategic operations in the areas of regulatory affairs. Participated on strategic teams including those pertaining to product / pipeline, operational readiness, human resource change and diversity and inclusion; identified risk areas and developed alternative courses of action. Member of AWM Strategic and AWM R&D Councils providing regulatory strategy and direction. Provided due diligence for potential product / company acquisitions and licensures. Developed yearly operating budget of greater than $7M and subsequent 5‐year strategic plan.
Galderma Laboratories, Ltd., Fort Worth, Texas 1998-2003
Regulatory Affairs Manager
Responsible for the preparation, review, submission and approval of IND and NDA applications and all subsequent interactions with the FDA. Managed the regulatory review process for all product and promotional labeling and advertising. Performed regulatory due diligence on potential product acquisitions and licenses. Provided regulatory representation on internal and external project teams to include product licensing and new product development. Responsible for yearly operating budget and 3‐ year strategic plan.
Carrington Laboratories, Inc., Irving, Texas 1997-1998
Regulatory Affairs Manager
Responsible for the preparation, review and submission of 510(k), IND, IDE, PMA, and NDA applications and all subsequent interactions with the FDA. Managed the regulatory review process for all product and promotional labeling and advertising. Coordinated the compilation of international medical device and drug registration submissions as well as CE Mark activities to include CE technical file creation and Notified Body audits. Served as Regulatory Affairs contact for audits with FDA, Texas Department of Health and European Notified Bodies.
Smith & Nephew, Inc., Largo, Florida 1992 ‐ 1997
Regulatory Affairs Manager / Head of Microbiology / Company Microbiologist
Responsible for all daily regulatory activities to include 510(k) submissions, labeling approvals and product listings. Managed implementation of ISO certification process and CE Mark activities. Served as lead auditor for internal and external audits, to include suppliers, contract manufacturers and other corporate divisions. Responsible for the creation and management of microbiology laboratory to support all QC and R&D activities. Provided microbiological consultation and training for internal personnel, other corporate divisions and contract manufacturers. Served as interim Quality Manager supervising personnel over three manufacturing work shifts.
UNIVERSITY OF SOUTH FLORIDA, Tampa, FL ‐ Master of Science Degree in Microbiology
MESSIAH COLLEGE, Grantham, PA ‐ Bachelor of Science Degree in Biology, Pennsylvania State Instruction I Certificate (Grades 7 – 12)
Regulatory Affairs Certification (RAC)
Drug Information Association (DIA) Regulatory Affairs Professional Society (RAPS)
The Organization for Professionals in Regulatory Affairs (TOPRA) Canadian Association of Professionals in Regulatory Affairs (CAPRA)