Intern, Regulatory Affairs - Summer 2025

Chiesi
United States, North Carolina, Cary
175 Regency Woods Place (Show on map)
Jan 15, 2025
*About us* Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. *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. *What we offer* Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi." *Who we are looking for* Purpose The Chiesi Regulatory Affairs internship will be an immersive experience that will include exposure to several regulatory projects directly related to the development of drugs and biologics. Education and training may include some FDA and Industry Sponsored lectures, but the focus will be a mainly on-the-job training experience. Main Responsibilities Global Regulatory Affairs Project Coordination: Coordinating aspects of communication and activities related to Global Rare Disease project execution Prepare agendas and attend internal meetings for internal initiatives and development plans for specific products. Coordinate authoring and review of U.S. regulatory submissions Quality Assurance and Quality Control review of U.S. regulatory submissions and internal documents Maintenance of Global Rare Disease Regulatory Affairs trackers, databases, and other internal resources. Additional Responsibilities: Support Regulatory Intelligence Activities Experience Required Strong organizational and planning skills Strong knowledge of MS Office Suite - Word, Excel, PowerPoint Exceptional communication in English - verbal and written Detail oriented Project coordination experience an asset Must be detail- and goal-oriented, quality conscientious, and results-oriented. An ability to manage changing priorities, multiple tasks, and communicate impact to project teams is required. Education Must be actively enrolled in an accredited college or university program, Master's or PharmD/Doctoral preferred. 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, sexual orientation, marital status, veteran status, gender identity or expression 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.