Director of Regulatory Affairs

About the role

F2G Pharmaceuticals is recruiting for an agile, highly motivated Director of Regulatory Affairs to manage FDA interactions and submission activities for F2G. The Director of Regulatory Affairs under the direction of the VP of Regulatory Affairs will be responsible for providing 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.

Key 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
• 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
• 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

What You Bring to the Table

• 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
• 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.