Regulatory Strategy

  • Experienced leaders in regulatory affairs and drug development
  • Provide US and Global Regulatory strategy for development programs.
  • Act as US Agent to FDA.
  • Provide High Level Strategic Regulatory Advice to Board of Directors, CEOs, and Senior Management.
  • Integrate into project teams and adapt to Sponsor ways of working.
    Collaborate with teams to proactively solve problems.
  • Expertise across therapeutic areas and treatment modalities (e.g., small molecules, monoclonal antibodies, bispecific antibodies, ADCs, RNA therapeutics, etc.)
  • Lead, prepare and implement Health Authority Interactions and Meetings.
  • Successfully obtain key designations to facilitate development, such as Fast Track Designation, Breakthrough Therapy Designation, Orphan Designation, Rare Pediatric Disease Designation, and Qualified Infectious Disease Product Designations.
  • Lead all aspects of IND, BLA, and NDA filings and review.
  • Provide guidance on 505(b)(2) applications.
  • Obtain Health Authority agreement on US Pediatric Plans/Exclusivity and EU PIPs.
  • Perform due diligence for companies and/or products.
  • Develop Global Regulatory Strategic Plans.
  • Provide leadership for Critical Issue Management with Health Authorities.
  • Drive initiatives including Label Claims/Labeling Strategy, Promotional Claims.
  • Review Advertising and Promotional materials.
  • Perform Regulatory Intelligence.
  • Advisory Committee preparation.
  • 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 SOPs to ensure compliance.

Medical Writing

  • Author strategic regulatory documents such as Requests for Fast Track, Breakthrough, Orphan, Rare Pediatric Disease, Qualified Infectious Disease Product Designations.
  • Develop IND/NDA/BLA/MAA High Level Summaries.
  • Lead Health Authority briefing package authoring (pre-IND, EOPI, EOPII, pre-NDA/BLA, Scientific Advice).
  • Write Pediatric Study Plans (PSP) and Pediatric Investigational Plans (PIP).
  • Develop General Investigational Plan for initial INDs.
  • Author key study documents including Investigator Brochures, Protocols, Informed Consents, Clinical Study Reports.
  • Lead authoring of Advisory Committee Briefing Packages.
  • Support teams in writing Responses to Health Authority Requests.
  • Write publications.

Regulatory Operations and Submissions

  • Deliver high quality submissions to Health Authorities
  • Submit all original applications (IND, NDA, BLA) in eCTD via validated electronic submissions gateway (ESG)
  • Build eCTD dossiers to enable global submission (e.g., MAA)
  • Perform submission publishing for all components of applications (e.g., protocol amendments, information amendments, responses to FDA questions, Office of Prescription and Drug Promotion materials)Publish and submit FDA briefing packages
  • Document publish any document for Health Authority submission in compliance with eCTD standards
  • Publish and submit Orphan drug applications
  • Manage regulatory  submissions lifecycle
  • Lead and Manage Submissions to Health Authorities
  • Advise on Internal Regulatory Operations Structure and Processes
  • Interact as Regulatory Operations Lead with Vendors
  • Able to submit to Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM)Electronic Submissions Gateway (ESG)
  • Publish Investigational Medicinal Product Dossiers (IMPD) and components for Clinical Trial Applications (CTA)