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Chiesi USA, Inc. · 15 hours ago

Intern, Regulatory Affairs, Global Rare Diseases - Summer 2026

Cary, NC

Internship

Hybrid

Intern

Start in 2026 Summer

Chiesi USA, Inc. is an international biopharmaceutical group focused on promoting a healthier world. They are seeking a Regulatory Affairs Intern to gain hands-on exposure to the regulatory lifecycle of innovative therapies for rare diseases, supporting regulatory teams and participating in strategic discussions.

BiotechnologyMedicalPharmaceutical

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

Qualification

Regulatory affairsDrug developmentFDA regulationsMicrosoft OfficeScientific analysisCuriosityAttention to detailCommunication skillsTeam collaborationProject management

Required

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