Vice President, Regulatory Affairs
Core
Lead all aspects of the company's regulatory function, spanning strategy and operations across CMC and clinical regulatory activities for a veterinary longevity drug.
Role type
Vice President, Regulatory Affairs
Builds
Regulatory submissions and approval packages for small molecule veterinary drugs
Domain
Veterinary medicine / Longevity drugs / Small molecule drug development
Required skills
CMC regulatory strategy, small molecule drug development, agency interactions, post approval lifecycle management, regulatory organization building, global regulatory intelligence, eCTD standards, IND strategy, labeling strategy
Preferred skills
Human health pharmaceutical experience, FDA CVM regulations, veterinary drug approval pathway (NADA/ANADA)
Responsibilities
Own and drive overall regulatory strategy across all active programs; Provide regulatory input into portfolio planning and business development; Develop and maintain global regulatory intelligence capabilities; Provide regular regulatory updates and risk assessments to executive leadership; Lead all CMC regulatory activities including filing strategy and CDMO oversight; Lead clinical regulatory activities including IND strategy and study report oversight; Own the approval submission strategy and execution; Serve as the company's primary liaison with regulatory agencies globally; Manage post approval regulatory obligations; Own labeling strategy and content development; Establish regulatory information management infrastructure; Build and lead a high performing regulatory organization; Establish regulatory governance frameworks; Serve as the company's independent regulatory authority; Foster a culture of regulatory excellence
Seniority
Executive, strategic leadership & operational execution