Regulatory Affairs Internship jobs in United States
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MannKind Corporation · 16 hours ago

Regulatory Affairs Internship

MannKind Corporation is a biopharmaceutical company focused on transforming chronic disease care through innovative solutions. They are seeking a Regulatory Affairs Intern to assist with the development of Drug Master Files, collaborate with various teams, and ensure compliance with regulatory requirements.

BiotechnologyHealth CarePharmaceutical
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Growth Opportunities
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Responsibilities

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

Qualification

Regulatory AffairsPharmaceutical SciencesBiotechnologyMicrosoft OfficeWritten CommunicationVerbal CommunicationOrganizational SkillsProblem-Solving SkillsInterpersonal SkillsAttention to Detail

Required

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)
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

Preferred

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

Company

MannKind Corporation

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MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions.

Funding

Current Stage
Public Company
Total Funding
$475M
Key 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

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Michael Castagna
Chief Executive Officer
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Christopher Prentiss
Chief Financial Officer
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Company data provided by crunchbase