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Position:
Executive Director, Regulatory Affairs
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Job Id:
1112674
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# of Openings:
1
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MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary:
We are growing our regulatory leadership team and are seeking a strategic, execution-oriented Associate Director / Director of Regulatory Strategy with a strong foundation in Regulatory CMC and a collaborative mindset that extends across development, 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 CMC 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 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 CMC Strategy: Provide regulatory direction across drug substance, drug product, device components, and packaging/labeling - particularly for inhalation products and drug-device combinations.
- Collaborate Cross-Functionally: Partner with Technical Operations, Quality, Clinical, and Commercial to anticipate regulatory risks, support change control, and inform development strategy from early through late phases.
- 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 and CMC innovation.
Education and Experience Qualifications:
- A Bachelor's Degree in Science of Life Science or Engineering or equivalent (MS preferred).
- 15+ years of progressive regulatory experience in biotech or pharma, with substantial responsibility for Regulatory CMC 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 strategy.
- Preferred:
- Have experience with global CMC 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
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Pay Range: $216,000 - $324,000 per hour
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Apply for this Position
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Mannkind Corporation
Sep 11, 2025 