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
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