Intern, Regulatory Affairs, Global Rare Diseases - Summer 2026

Chiesi USA • Cary, NC

8d • Hybrid

About The Position

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work. Internship Program Overview Our 10-week summer internship program gives students hands-on experience and the opportunity to make a meaningful impact while learning about our organization. Interns will connect with leaders, participate in development sessions like self-assessments and business overviews, and take part in networking and community initiatives. The program concludes with a final presentation to leaders and peers, where interns showcase their work, share ideas, and receive valuable feedback. 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.

Requirements

• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Career Level: Intern