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- 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.
- 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)