Regulatory Affairs Internship at MannKind USA
Looking to break into Biotechnology careers with real-world impact? This regulatory affairs internship at MannKind Corporation in the USA offers a rare opportunity for life science students and recent graduates to gain hands-on experience in regulatory documentation, Drug Master Files (DMFs), and FDA-aligned compliance. Ideal as a job opportunity for life science graduates, this internship in USA places you inside a fast-growing biopharmaceutical company transforming chronic disease care.
About MannKind
MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. The company focuses on cardiometabolic and orphan lung diseases and develops treatments addressing 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.
MannKind fosters a close-knit, collaborative culture and values a diverse range of backgrounds, perspectives, and working styles. Employees are considered the company’s greatest asset and play a vital role in improving health outcomes and changing lives.
Regulatory Affairs Internship Details:
- Internship Title: Regulatory Affairs / Drug Master File Support Summer Internship Program
- Company: MannKind Corporation (Nasdaq: MNKD)
- Industry: Biopharmaceuticals
- Location: Bedford / Burlington, Massachusetts, United States
- Work Model: Full-time (On-site Monday–Thursday, Remote Friday)
- Program Dates: June 15 – August 20, 2026
- Schedule: Full-time; On-site Monday–Thursday, Remote Friday
- Commute: A reliable commute or intention to secure temporary housing prior to the internship is required
Role Overview
The intern will support regulatory-focused initiatives related to the development of standalone Drug Master Files (DMFs). The role involves cross-functional collaboration, document preparation, and support of regulatory compliance activities aligned with FDA, ICH, and global regulatory requirements.
Key Responsibilities
- Assist with the development of standalone Drug Master Files (DMFs)
- Collaborate with Quality, Manufacturing, and R&D teams to compile required source materials
- Support preparation, organization, and drafting of DMF components, including:
- Administrative information
- Manufacturing process documentation
- Quality and compliance sections
- Analytical method summaries and specifications
- Conduct literature reviews and data gathering to support accuracy and completeness of DMF content
- Review technical documents for consistency, formatting, and regulatory alignment
- Support compliance with FDA, ICH, and global regulatory requirements
- Maintain version control and document tracking for DMF submission elements
Candidate Profile
Required Qualifications
- Currently pursuing a Bachelor’s or Master’s degree in Regulatory Affairs, Biotechnology, Life Sciences, or a related field
- Strong interest in pharmaceutical and biotechnology regulatory frameworks and compliance
- Strong written and verbal communication skills
- Self-motivated with demonstrated learning agility
- Detail-oriented with strong organizational and documentation skills
- Ability to collaborate and manage multiple tasks in a fast-paced environment
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Preferred Qualifications
- Preferably within 1–2 years of graduation
- Strong analytical, interpersonal, organizational, and problem-solving skills
- Excellent attention to detail with the ability to work independently
- Demonstrated initiative in identifying and acting on improvement opportunities
- Openness to constructive feedback and commitment to professional growth
Why This Regulatory Affairs Internship Opportunity?
MannKind’s Summer Internship Program provides hands-on experience in the biotech industry across departments such as Research & Development, Technical Operations, Human Resources, Finance, Legal, and Clinical Operations. Interns gain exposure to meaningful projects, mentorship from industry professionals, and opportunities to contribute to innovative and impactful work.
