Senior Director, Regulatory Affairs, CMC

Qualification

A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline and 12+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, including significant Regulatory CMC experience supporting late-stage development and/or commercial products. Experience in managing commercial programs marketed in US, EU, Canada and other major markets Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations in US and other major markets. Demonstrated track record of successful global regulatory submissions and strategies. Prior Regulatory Agency liaison experience is desirable. Strong competency in understanding global regulatory requirements and the emerging regulatory landscape. Detail oriented with excellent written and verbal communication and presentation skills. Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members. Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs. Ex