Description
Under the direction of the Vice President, Regulatory Affairs:
- Provide strategic and operational regulatory direction on projects including, but not limited to regulatory strategies, regulatory requirements for clinical studies and marketing approvals in the US market, regulatory strategic development plans and risk assessments
- Contributes to the planning and preparation of regulatory submission of IND, NDA, ODDs and eCTD dossier filings and related submissions, including preparation of meeting packages and responses to Health Authority (HA) inquiries as delegated
- Performs critical review of submission documents to ensure compliance with regulatory requirements. May provide regulatory input for and appropriate follow-up to inspections, audits and product complaints
- Serves as the Regulatory representative on specific multi-discipline teams to provide guidance to all appropriate departments to ensure compliance with applicable regulations, and is expected to be responsible for organizing and leading meetings
- Reviews and interprets related product approval information and current relevant HA guidance and Advisory Committee meetings
- Support due diligence assessments including risk mitigation strategies
- Makes recommendations for regulatory department operating procedures and may be responsible for creating and reviewing SOPs as needed
Requirements
- Bachelor's degree or an advanced degree (MS/PharmD or PhD)
- At least 10 years of relevant regulatory affairs
- Knowledge of FDA organizational structure and FDA processes for reviewing submissions is required
- Prior experience with NDA submission and the ability to successfully manage projects to deadlines are required
- Orphan drug experience is preferable and/or therapeutic area experience is preferred
- Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
- A proven ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects is beneficial
- The ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
- Excellent oral and written communication skills, as well as strong organization and multi-tasking skills are required.
Summary
F2G is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides have a distinct mechanism of action, selectively targeting fungal dihydroorotate dehydrogenase (DHODH), a key enzyme in the de novo pyrimidine biosynthesis pathway. This differentiates the orotomides from the currently marketed antifungal agents.
Olorofim (formerly F901318) is F2G’s leading candidate from this class and has fungicidal activity against a broad range of mold infections, including a variety of rare and resistant molds that cause life-threatening infections for which current therapies have limitations or are ineffective. Olorofim has recently completed enrollment in a Phase 2b open-label study focusing on rare and resistant invasive fungal infections including invasive aspergillosis (including azole-resistant strains), coccidioidomycosis, and scedosporiosis (including lomentosporiosis). F2G has also initiated a global Phase 3 trial to expand on the studied population. Olorofim has received orphan drug status from the European Medicines Agency and orphan drug status, Qualified Infectious Disease Product (QIDP) designation and Breakthrough Therapy designation from FDA.