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 http://www.chiesiusa.com.
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