Intern, Regulatory Affairs, Global Rare Diseases - Summer 2026

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. As a Regulatory Affairs Intern, you will gain hands-on exposure to the regulatory lifecycle of therapies for rare diseases, supporting teams in regulatory activities and document preparation while participating in strategic discussions.

Responsibilities

• 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

Skills

• 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
• 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

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