Associate Director, Regulatory Strategy

Role Summary

Associate Director of Regulatory Strategy responsible for global regulatory leadership for development programs and marketed products, with emphasis on cardio/renal drug-device combination product strategy, and collaboration across development, CMC, clinical, and operations.

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‚Äîensuring 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‚Äîparticularly for injectable and inhalation drug-device combinations; conduct change control impact assessments and prepare associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
• Collaborate Cross-Functionally: Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory 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 ensure MannKind remains at the forefront of combination product innovation.

Qualifications

• 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 responsibility for Regulatory across all stages of development. Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g. Human Factors, bridging strategies).
• Proven track record of successful interactions with the FDA and/or global regulatory agencies.
• Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
• Strong writing, communication, and leadership skills‚Äîwith the ability to translate complex issues into actionable strategies.
• Preferred:
  • Have experience with global regulatory submissions (e.g., US FDA EMA, Health Canada, PMDA).
  • Have worked on 505(b)(2) development strategies or innovative delivery platforms.
  • Enjoy mentoring or shaping regulatory frameworks in emerging therapeutic areas.

Skills

• Regulatory strategy and planning
• FDA and global regulatory engagement
• Technical writing and submission preparation
• Cross-functional collaboration
• Leadership and strategic thinking

Education

• Bachelor's degree in Life Science or Engineering (required); advanced degree preferred as specified in qualifications.