Intern, Regulatory Affairs, Global Rare Diseases - Summer 2026

This is what you will do

As a Regulatory Affairs Intern within Chiesi Global Rare Diseases, you will gain hands-on exposure to the end-to-end regulatory lifecycle of innovative therapies for rare diseases in the United States. This role offers a unique opportunity to understand how regulatory strategy directly enables product development, approval, and post-marketing success, while working alongside experienced regulatory professionals in a collaborative, mission-driven environment. The internship provides a strong foundation for a future career in regulatory affairs, clinical development, or related functions within the biopharmaceutical industry. 

You’ll be responsible for:

• Supporting regulatory teams in pre- and post-marketing activities for rare-disease products in the U.S. 
• Assisting with the preparation, review, and organization of regulatory documents and submissions (e.g., INDs, BLAs/NDAs, supplements, amendments, and responses to FDA information requests). 
• Conducting background research on FDA regulations, guidance, and regulatory precedents relevant to rare diseases and advanced therapies. 
• Tracking regulatory commitments, milestones, and timelines in collaboration with cross-functional stakeholders. 
• Participating in internal regulatory strategy discussions and selected cross-functional meetings (e.g., Clinical, CMC, Quality, Commercial). 
• Supporting internal process improvement initiatives, including document management, compliance tracking, or knowledge-sharing activities. 
• Preparing summaries, slide decks, or briefing materials for internal reviews and leadership discussions. 
• Completing a defined internship project and delivering a final presentation to leaders and peers at the conclusion of the program. 

You will need to have

• Currently pursuing a master’s or doctoral program in life sciences, pharmacy, public health, regulatory science, or a related discipline with an expected graduation of fall 2026 or later. 
• Strong interest in regulatory affairs and drug development, particularly within rare diseases. 
• Basic understanding of the pharmaceutical or biotechnology development process. 
• Ability to analyze and synthesize scientific or regulatory information. 
• Strong written and verbal communication skills. 
• Attention to detail and ability to manage multiple tasks concurrently. 
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint). 
• Ability to work collaboratively in a cross-functional, team-based environment. 
• Professionalism, integrity, and respect for confidentiality. 

We would prefer for you to have

• Coursework or prior exposure to regulatory affairs, FDA regulations, or drug development. 
• Familiarity with FDA regulatory pathways (e.g., IND, NDA, BLA, orphan drug designation). 
• Interest in rare diseases, gene therapies, biologics, or advanced therapeutic modalities. 
• Prior internship or research experience in the pharmaceutical, biotech, or healthcare sector. 
• Experience reviewing or summarizing scientific literature. 
• Comfort working with technical or regulatory documentation. 
• Strong organizational and project-management skills. 
• Experience collaborating in a matrixed or global environment. 
• Curiosity and willingness to ask thoughtful questions. 
• Interest in a long-term career within the biopharmaceutical industry. 

Location

This is a hybrid role based in either Cary, NC or Boston, MA. Interns are expected to work on-site up to 3 days per week.