Regulatory Affairs Internship

MannKind's Summer Internship Program offers an exciting, hands-on experience in the biotech industry. Interns can work in departments like R&D, Tech Ops, Human Resources, Finance, Legal and Clinical Operations. As an intern, you will tackle important projects, receive mentorship from industry experts, and build valuable connections. Our program emphasizes innovation, giving you the chance to contribute to groundbreaking projects and cutting-edge solutions. Develop your skills, gain real-world experience, and make a meaningful impact in healthcare. What You'll Be Doing: Assist with development of standalone Drug Master File (DMF) generation Collaborate with Quality, Manufacturing, and R&D teams to compile required source materials. Support the preparation, organization, and drafting of DMF components, including administrative information, Manufacturing process documentation, Quality and compliance sections, Analytical method summaries and specifications Assist with literature review and data gathering to support DMF content accuracy and completeness. Review technical documents for consistency, formatting, and regulatory alignment. Help ensure that all documentation complies with FDA, ICH, and global regulatory requirements. Maintain version control and document tracking for DMF submission elements. What You Bring to the Table: Currently, pursuing a Bachelor’s or Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences, or related field. Strong interest in regulatory frameworks and compliance in the pharmaceutical/biotech sector. Strong written and verbal communication skills Self-motivated and demonstrated learning agility Detail‑oriented with strong organizational and documentation abilities. Ability to work collaboratively and manage multiple tasks in a fast‑paced environment. Proficiency in Microsoft Office (Word, Excel, PowerPoint) Bonus Points If You Have: Preferably within 1-2 years of graduation Strong analytical, interpersonal, organizational, and problem-solving skills Excellent attention to detail and ability to work independently You take the initiative to identify opportunities for improvement and act on them without needing constant direction. You are open to constructive criticism and use it to improve performance and grow professionally When and Where You'll Shine: Full-time: Schedule (Onsite Mon–Thu, Remote Fri) Location: Bedford/Burlington MA Dates of Program: June 15 to August 20, 2026 A reliable commute or the intention to find temporary housing before starting the internship is required. At this time, we are only able to consider candidates who do not require visa sponsorship, including those with a student visa.