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 Company Overview Chiesi USA is a pharmaceuticals company specializing in pharmaceutical research & development services. It was founded in 2014, and is headquartered in Cary, North Carolina, USA, with a workforce of 201-500 employees. Its website is