Director, Regulatory Affairs

A clinical-stage biotech is seeking a Director, Regulatory Affairs to support regulatory strategy and execution across its development pipeline. This is a hands-on, high-impact individual contributor role that will partner closely with Clinical Development, R&D, and Quality teams to advance programs through key regulatory milestones while ensuring alignment with FDA and global regulatory requirements. This is an exciting opportunity to join a growing, innovative biotech and play a key role in shaping the regulatory strategy for multiple development programs.

Key Responsibilities:

• Lead regulatory strategy and execution for assigned development programs
• Support the preparation and submission of regulatory filings, including INDs and marketing applications
• Provide regulatory guidance to cross-functional teams throughout the development lifecycle
• Assess regulatory risks and develop mitigation strategies
• Support regulatory interactions and communications with health authorities
• Ensure compliance with FDA and international regulatory requirements

Qualifications:

• 10+ years of Regulatory Affairs experience within biotech or pharma
• Strong experience supporting clinical-stage development programs
• Proven track record contributing to regulatory strategy and submissions
• Working knowledge of global regulatory frameworks, including FDA, EMA, and other international agencies
• Strong communication, collaboration, and stakeholder management skills
• Oncology experience strongly preferred