Sr. Director, Regulatory Affairs

Key Responsibilities

• Lead the development and execution of global regulatory strategies for assigned development programs from early development through commercialization.
• Serve as the regulatory strategy lead for health authority interactions on assigned programs, including FDA and ex-U.S. regulatory agency interactions.
• Provide strategic guidance on regulatory pathways, submission strategies, expedited programs, scenario plans, and risk mitigation plans.
• Lead the preparation, review, and submission of regulatory documents, including INDs, IND amendments, CTAs, briefing packages, meeting requests, annual reports, and other assigned regulatory applications.
• Represent Regulatory Affairs on cross-functional program teams and provide regulatory leadership across Clinical, Nonclinical, CMC, Quality, and Commercial functions.
• Drive regulatory timelines and ensure high-quality, compliant submissions aligned with corporate objectives.
• Build and maintain strong working relationships with regulatory agencies and external partners for assigned programs, including regulatory CROs, consultants, and alliance or business partners as applicable.
• Monitor evolving global regulatory requirements and assess potential impact on assigned development programs to guide business strategy.
• Contribute to organizational growth, process improvements, and development of regulatory infrastructure and best practices.
• Mentor and support junior regulatory team members as the organization continues to scale.

Requirements

• Bachelor’s degree required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred.
• Minimum of 10 years of regulatory affairs experience within biotechnology and/or pharmaceutical industry, with at least 5 years in leadership role(s).
• Strong experience supporting regulatory strategy and submissions across multiple stages of development.
• Demonstrated success leading FDA or equivalent Health Authority interactions and major regulatory submissions.
• Experience with global clinical trial applications inclusive of China, Europe, and/or Australia preferred.
• Experience in rare disease, immunology, nephrology, infectious disease, or related therapeutic areas preferred.
• Deep understanding of global regulatory requirements and drug development processes.
• Strong communication, leadership, and influencing skills with the ability to work effectively across functions and levels.
• Proven ability to thrive in a dynamic, fast-paced biotech environment.