MannKind Corporation · 2 weeks ago
Sr. Manager, Regulatory Affairs CMC
Burlington, MA
Full-time
Hybrid
Senior Level
7+ years expMannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. The Sr. Manager, Regulatory Affairs CMC will oversee and execute regulatory CMC strategy for drug-device combination products, ensuring compliance and providing strategic guidance to project teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develop regulatory CMC strategy in collaboration with project team for drug-device combination products including authoring and review of regulatory submissions (INDs, NDAs, DMFs, etc) and review of Product, Manufacturing, and Quality documentation (specifications, product development reports and protocols, NCRs, CAPAs, etc.)
Support labeling generation, updates, and implementation for both new product development and updates to approved labeling documentation, including Prescribing Information, Instructions for Use, and applicable printed components of product packaging
Participate in and/or lead development of CMC related change controls. Evaluate regulatory and quality documentation impact of post-approval changes to product, process, materials, etc. and serve as Regulatory expert in developing plans for implementation of planned changes, including management and preparation of required regulatory submissions
Manage preparation and submission of periodic reports, including annual reports to regulatory bodies, as applicable
In collaboration with Regulatory and Quality Management, manage process for field action reporting, product recall, and associated actions and communications if product is determined to not meet quality requirements
Identify and implement improvements in CMC-related procedures and processes to enhance efficiency and maintain compliance with evolving regulatory requirements
Qualification
Required
Bachelors in a relevant scientific discipline (Chemistry, Chemical Engineering, Pharmaceutical Development, etc.) with a minimum of 7-10 years' experience in Product development and manufacturing, CMC, Regulatory, or Quality
Expertise in CMC-related regulatory requirements, FDA guidances, and associated standards
Expertise in preparation and review of regulatory submission documentation, including US and ex-US meeting documents, INDs/CTAs, NDAs/MAAs, etc
Knowledgeable in post-approval product and manufacturing change assessments for drug-device combination products
Knowledgeable of good manufacturing practices, good documentation practices
Knowledge of project management tools and techniques to ensure timely and effective completion of multidisciplinary deliverables
Teamwork & Leadership: Cross functional influencer and network builder; attunes roles, responsibilities and expectations of x-functional teams and stakeholders to cultivate innovation and deliver results; mentors/guides diverse stakeholders
Execution: Consistently directs, drives and holds others accountable for cross-functional results; identifies ambiguity and a path forward; removes obstacles to facilitate work
Solution Maker: With strategic mindset, distills complex and ambiguous information and leverages teams and internal/external networks to deliver x-functional solutions; role models approach and inspires others to create solution
Continuous Improvement: Create new and better ways for x-functional teams to be successful; develops and leverages strengths of individuals and teams; and inspires others to anticipate problems and plan for success; seeks new ways to learn and be challenged
Awareness: Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions
This position will be expected to travel to vendor facilities such as manufacturing sites periodically to observe manufacturing processes, coordinate and manage investigations, support audits, etc
Up to 20% travel time
Preferred
Advanced degree in a related scientific field and/or cross-functional experience preferred
Experience with drug-device combination products preferred
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