Associate Director, Regulatory Strategy

Role Summary

Strategic, execution-oriented Associate Director of Regulatory Strategy with a strong foundation in drug-device combination product development, collaborating across development, CMC, clinical, and operations. Lead global regulatory strategy for assigned development programs and marketed products, focusing on cardio/renal drug-device combinations and providing regulatory input across development and lifecycle management.

Responsibilities

• Define & Drive Global Strategy: Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of cardio/renal drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
• Lead Regulatory Interactions: Prepare and represent MannKind in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), focusing on CMC, clinical and combination product matters.
• Regulatory Planning & Submissions: Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents—ensuring strategic alignment and technical rigor.
• Own Development and Lifecycle Strategy: Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling—particularly for injectable and inhalation drug-device combinations; conduct change control impact assessments and prepare regulatory submissions for post-approval changes in compliance with regulatory requirements.
• Collaborate Cross-Functionally: Partner with Technical Operations, Quality, Clinical, and Commercial functions to identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle plans from early development through late-stage and post-commercialization activities.
• Shape the Path Forward: Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to stay at the forefront of combination product innovation.

Qualifications

• Required: A bachelor’s degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a master’s degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development; experience with combination products (e.g., inhaled, injectable, or wearable systems) and understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
• Required: Proven track record of successful interactions with the FDA and/or global regulatory agencies.
• Required: Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
• Required: Strong writing, communication, and leadership skills—with the ability to translate complex issues into actionable strategies.
• Preferred: Have experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
• Preferred: Have worked on 505(b)(2) development strategies or innovative delivery platforms.
• Preferred: Enjoy mentoring or shaping regulatory frameworks in emerging therapeutic areas.

Education

• Bachelor’s degree in Life Science or Engineering with 12+ years of progressive regulatory experience; or Master’s degree with 8+ years; or Ph.D. with 5+ years in biotech or pharma, with substantial regulatory responsibility across all development stages. Experience with combination products and understanding of applicable FDA regulations and guidance.