MannKind Corporation · 2 weeks ago
Associate Director, Regulatory Strategy
Burlington, MA
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expMannKind Corporation is a biopharmaceutical company focused on transforming chronic disease care through innovative solutions. They are seeking an Associate Director of Regulatory Strategy to lead global regulatory efforts for drug-device combination products, ensuring strategic alignment and collaboration across various functions.
BiotechnologyHealth CarePharmaceutical
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), 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
Qualification
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 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
Company
MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions.
501-1000 employees
H1B Sponsorship
MannKind Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (6)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$475MKey Investors
Blackstone GroupDeerfield Capital Management
2025-08-06Post Ipo Debt· $75M
2021-03-02Post Ipo Debt· $200M
2018-12-01Post Ipo Equity· $40M
Leadership Team
Michael Castagna
Chief Executive Officer
Christopher Prentiss
Chief Financial Officer
Recent News
2026-01-09
GlobeNewswire
2025-12-24
2025-12-24
Company data provided by crunchbase