The FDA Group's Consultant Finder

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Written by The FDA Group | Mar 10, 2022 4:26:55 PM

Key Areas of Expertise

  • Regulatory Strategy and Health Authority Interactions
  • IND/NDA/BLA/NDS/MAA/CTA and 510(k)/PMA Dossiers
  • Pharmacovigilance and Safety Reporting
  • Product Lifecycle Management and Due Diligence
  • Global Regulatory Compliance and CMC Management
  • Training and Development in Regulatory Affairs

Professional Experience

President / Principal Consultant – Drais Regulatory Consulting, LLC
Various Locations | 2020-Present

  • Provides regulatory consulting to support biologics, biosimilars, advanced therapy products, pharmaceuticals, medical devices, and cosmetics globally.
  • Develops regulatory strategies and classifications for optimal project progression from product development through post-market compliance.
  • Leads health authority interactions, accelerated regulatory pathways, and oversees regulatory document preparation across product lifecycles.
  • Conducts regulatory intelligence and due diligence for both product and company assessments, and delivers customized training sessions on regulatory history, product development, and compliance.

Head of Global Regulatory Affairs, Prescription Strategic Innovation Group – Galderma Research & Development, LLC
Fort Worth, TX | 2017-2020

  • Planned and managed regulatory activities to support global prescription product development, leading all interactions with FDA, EMA, Health Canada, and other authorities.
  • Established and led the Global Regulatory Affairs function, including organizational design, recruitment, and process development for efficient regulatory operations.
  • Managed global regulatory project management, market support, CMC compliance, regulatory intelligence, and scientific writing, with a budget exceeding $5 million.
  • Member of the Prescription Strategic Innovation Group Executive Leadership Team, contributing to strategic and operational planning for new products and due diligence for acquisitions.

Vice President, Regulatory Affairs – Smith & Nephew Inc. / Healthpoint, Ltd.
Fort Worth, TX | 2003-2016

  • Directed global regulatory functions across Advanced Wound Management, overseeing dossiers for IND, BLA, CTA, NDS, MAA, IDE, and 510(k) approvals.
  • Successfully achieved the removal of a Boxed Warning for a biologic product, aligning labeling with global safety standards.
  • Built and expanded the Regulatory Affairs function to support organizational needs, serving as a key member of the Advanced Wound Management Executive Leadership Team.
  • Participated in strategic initiatives including product/pipeline development, operational readiness, and diversity programs, managing a regulatory budget of over $7 million and formulating a 5-year strategic plan.

Regulatory Affairs Manager – Galderma Laboratories, Ltd.
Fort Worth, TX | 1998-2003

  • Prepared, reviewed, and managed IND and NDA applications and regulatory submissions, coordinating FDA interactions and regulatory due diligence for potential product acquisitions.
  • Supported regulatory review processes for labeling and advertising compliance, developing regulatory strategies for both pre-market and post-market products.

Regulatory Affairs Manager – Carrington Laboratories, Inc.
Irving, TX | 1997-1998

  • Led preparation and submission of 510(k), IND, IDE, PMA, and NDA applications, managing labeling, advertising compliance, and CE Mark certification.
  • Coordinated international regulatory submissions and served as the regulatory lead for FDA, Texas Department of Health, and European Notified Body audits.

Regulatory Affairs Manager / Head of Microbiology – Smith & Nephew, Inc.
Largo, FL | 1992-1997

  • Managed daily regulatory activities, including 510(k) submissions and ISO certification processes, and served as lead auditor for internal and external audits.
  • Established a microbiology laboratory to support QC and R&D, providing consultation and training across divisions and serving as interim Quality Manager.

Education
Master of Science in Microbiology
University of South Florida, Tampa, FL

Bachelor of Science in Biology (with Pennsylvania State Instruction I Certificate, Grades 7-12)
Messiah College, Grantham, PA

Certifications and Professional Training

  • Regulatory Affairs Certification (RAC)

Professional Memberships

  • 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)

Accomplishments

  • Successfully led regulatory strategies to achieve critical product approvals across multiple therapeutic areas, including dermatology, oncology, wound care, and infection control.
  • Developed and implemented global regulatory frameworks, reducing submission timelines and improving compliance for large multinational companies.
  • Built and led high-performing regulatory teams, overseeing organizational expansion and aligning regulatory processes with business goals.

Skills

  • Strong leadership, analytical, and communication skills with expertise in dossier management, regulatory intelligence, and compliance across multiple product categories.
  • Proficient in strategic planning, regulatory training, and quality management for biologics, pharmaceuticals, medical devices, and combination products.
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