What are the responsibilities and job description for the Associate Director, Regulatory Strategy position at MannKind Corporation?
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
Position Summary:
We are growing our regulatory leadership team and are seeking a strategic, execution-oriented Associate Director of Regulatory Strategy with a strong foundation in drug-device combination product development and a collaborative mindset that extends across development, CMC, clinical, and operations.
Responsibilities include but are not limited to:
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), with particular focus 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. This includes conducting change control impact assessments and preparing 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.
Education and Experience Qualifications:
Lead Regulatory Interactions: Prepare and represent MannKind in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus 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. This includes conducting change control impact assessments and preparing 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.
Education and Experience Qualifications:
- 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 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—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).
- Have worked on 505(b)(2) development strategies or innovative delivery platforms.
- Enjoy mentoring or shaping regulatory frameworks in emerging therapeutic areas
