F2G · 17 hours ago
Director of Regulatory Affairs
United States
Full-time
Remote
Director/Executive
10+ years expF2G is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening invasive fungal infections. The Director of Regulatory Affairs will manage FDA interactions and submission activities, providing strategic and operational regulatory direction on projects related to regulatory strategies and marketing approvals.
BiotechnologyGeneticsHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
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
Role will require a minimum of 20% travel to the US HQ (Princeton), UK, Europe & other countries as needed to work with internal team members, project teams, etc
Preferred
Orphan drug experience is preferable and/or therapeutic area experience is preferred
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
Company
F2G
F2G discovers and develops novel drugs for the treatment of life-threatening fungal diseases.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$383.32MKey Investors
AMR Action Fund,Intermediate Capital GroupForbion Capital Partners,Sofinnova PartnersCowen Healthcare Investments
2024-09-12Series H· $100M
2022-08-04Private Equity· $70M
2020-08-12Private Equity· $60.8M
Leadership Team
Ian Nicholson
Chief Executive Officer
Mike Birch
Chief Operating Officer
Recent News
DelveInsight Business Research LLP
2025-06-30
Company data provided by crunchbase