Coté Orphan conducts ongoing recruitment efforts to meet the needs of future vacancies. As we consistently grow, Coté Orphan is always interested in intelligent, ambitious, and experienced individuals to join our regulatory affairs or business development teams. Applications are kept on file for 6 months.
Business Development Associate
Experience in business development within the life sciences with a strong knowledge of biotechnology industry; understanding of FDA and EMA regulatory framework; and client-facing experience in consulting or agency work preferred.
Regulatory Affairs Associate
Experience in IND submission and management, NDA submissions, 505b2 submissions, orphan designation applications, and FDA meetings management. A strong, client-focused work ethic is mandatory, as is the ability to work independently on mission-critical projects. Writing and oral communication skills are essential. RAC preferred, previous FDA experience preferred, 7+ years regulatory experience preferred.