A fantastic new role has just emerged with our client - a clinical-stage Pre-IPO biotech who are dedicated in developing innovative therapies within Oncology. They are seeking a Director, Regulatory Affairs to join their growing regulatory team.

Job Responsibilities

• Provides regulatory and scientific leadership to ensure optimal development plans and regulatory success across US and international markets.
• Develops innovative regulatory strategies, represents the regulatory function on cross-functional teams, and coordinates submission planning for clinical trials and marketing applications (IND, CTA, NDA/BLA, MAA).
• Acts as primary contact with FDA and global health authorities, managing interactions, meetings, and documentation.
• Oversees regulatory maintenance plans, submission timelines, and works with teams to meet objectives.
• Guides and trains regulatory staff, providing feedback for professional development.
• Builds relationships with external partners and monitors regulatory intelligence to support ongoing development programs.
• Provides regulatory guidance to external departments and ensures continuous improvement through internal procedure revisions.

Job Qualifications

• A high-science degree required.
• A minimum of 5years of experience and a successful track record in clinical drug development in Oncology and/or Hematology.
• Experience working in both US and global markets.