Regulatory Affairs Internship
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Job Location:
Bedford, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases we develop and commercialize treatments that address 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.
At MannKind our employees are our greatest asset. We foster a close-knit collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds perspectives and working styles as we work together to improve health outcomes and change lives.
Why Youll Love This Opportunity:
MannKinds 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 Youll 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 Bachelors or Masters 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
- Detailoriented with strong organizational and documentation abilities.
- Ability to work collaboratively and manage multiple tasks in a fastpaced 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 Youll Shine:
- Full-time: Schedule (Onsite MonThu 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.
Required Experience:
Intern
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
