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Regulatory Strategy

  • Provide US and Global Regulatory strategy across therapeutic areas for drugs, biologics and vaccines
  • Act as US Agent to FDA
  • High Level Strategic Regulatory Advice to Board of Directors, CEO’s, and Senior Management
  • Lead, prepare and implement FDA Meetings
  • Advisory Committee preparation
  • 505(b)(2) Applications
  • Orphan Designations
  • Due diligence for product and companies
  • Successfully obtain Fast Track Designation, Breakthrough Therapy Designations and Qualified Infectious Disease Product Designations
  • Global Regulatory Strategic Plans
  • Critical Issue Management with Health Authorities
  • Risk Management and REMS
  • Label Claims/Labeling Strategy
  • Promotional Claims
  • US Pediatric Plans/Exclusivity and EU PIPs
  • Advertising and Promotion Input and Review
  • Regulatory Intelligence Services
  • Represent regulatory on senior management committees for drug development, labeling and pharmacovigilance
  • Advice and assist in hiring for regulatory positions, writing job descriptions, and setting up regulatory departments
  • Advise and write Regulatory SOP’s to ensure compliance

Medical Writing and Publications

  • Fast Track, Breakthrough Designation
  • IND/NDA/BLA/MAA High Level Summaries
  • Health Authority briefing packages (pre-IND, EOPI, EOPII, pre-NDA/BLA, Scientific Advice)
  • Pediatric Study Plans (PSP) and Pediatric Investigational Plan (PIP)
  • Investigator Brochures
  • Protocols/Informed Consent
  • IND Summaries/General Investigational Plan
  • Clinical Study Protocols/Study Reports
  • Advisory Committee Briefing Packages
  • REMS Assessment Reports
  • Responses to Health Authority Requests
  • Publications

Regulatory Operations and Submissions

  • All eCTD Submissions (IND, NDA, BLA)
  • Office of Prescription and Drug Promotion (OPDP)
  • Document publishing
  • Submission publishing
  • Orphan drug applications
  • Managing regulatory archived submissions
  • In-House or Remote Publishing
  • Lead and Manage Submissions to Health Authorities
  • Advise on Internal Regulatory Operations Structure and Processes
  • Interact as Regulatory Operations Lead with Vendors
  • Center for Veterinary Medicine (CVM)
  • Investigational Medicinal Product Dossier (IMPD)

Talent Care

  • Creation of Job Descriptions
  • Development of Employee Handbook
  • Manage Benefit Administration/Roll-out
  • Talent Acquisition and Onboarding
  • Performance Assessment/ Development Tools
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