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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