Intern, Regulatory Affairs, Global Rare Diseases

Chiesi USA

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.

Who we are looking for

This is what you will do

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.

You’ll be responsible for:

• 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.

You will need to have

• 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.

We would prefer for you to have

• 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.

Location

This is a hybrid role based in either Cary, NC or Boston, MA. Interns are expected to work on-site up to 3 days per week.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.