Title: Vice President Regulatory Affairs
A rapidly growing biotech in CA is seeking a highly experienced Regulatory Affairs professional to join the team as the VP Regulatory Affairs. This company has seen massive growth over the past decade and just had an incredible data readout. They are excited to welcome on a new member of the leadership team to oversee the RA functions and lead the NDA process though launch.
Responsibilities: Provide regulatory leadership through the regulatory strategy of product development and approvalProvide knowledge of global quality/regulatory guidelines and ensure requirements are met across programsPartner with internal senior leadership to collaborate on cross-functional projects and provide global regulatory plans to align with company objectivesHave ownership of relevant regulatory submission deliverablesProvide leadership and oversight of all critical global regulatory submissions (pre-IND through post-marketing) to FDA and RoW notified bodiesRepresent the Regulatory department in senior management discussions and present strategies, risk assessments, and recommendationsProvide hands on leadership for the Regulatory departmentQualifications: 15+ years of experience in Regulatory Affairs in biopharma/biotech/pharmaAdvanced degree preferred (MD, PhD, PharmD, MS)Previous NDA and small molecule experience is desiredHas experience managing multiple assets in a product pipelinePrevious managerial experience is preferredWell versed in drug development process and regulatory requirements, as well as a good understanding of the underlying scienceExcellent project management skills, with ability to manage multiple projects and prioritize appropriatelyAbility to rapidly understand & analyze complex problems/situationsAbility to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed
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