Associate Director, Regulatory Strategy

Role Summary

Associate Director of Regulatory Strategy with a strong foundation in drug-device combination product development, collaborating across development, CMC, clinical, and operations to lead global regulatory strategy and submissions for assigned development programs and marketed products.

Responsibilities

• Define & Drive Global Strategy: Serve as the global regulatory lead for assigned development programs and marketed products, owning cardio/renal drug-device combination product strategy and collaborating on 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 with strategic alignment and technical rigor.
• Own Development and Lifecycle Strategy: Provide regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling‚Äîespecially for injectable and inhalation drug-device combinations; conduct change control impact assessments and prepare regulatory submissions for post-approval changes in compliance with requirements.
• Collaborate Cross-Functionally: Partner with Technical Operations, Quality, Clinical, and Commercial to identify and mitigate regulatory risks, support global change control processes, and provide input to development and lifecycle management 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 keep MannKind at the forefront of combination product innovation.

Qualifications

• Required: A bachelor‚Äôs degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a master‚Äôs degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial regulatory responsibility across all development stages. 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: Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
• Preferred: Experience with 505(b)(2) development strategies or innovative delivery platforms.
• Preferred: Enjoy mentoring or shaping regulatory frameworks in emerging therapeutic areas.