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 approval
- Provide knowledge of global quality/regulatory guidelines and ensure requirements are met across programs
- Partner with internal senior leadership to collaborate on cross-functional projects and provide global regulatory plans to align with company objectives
- Have ownership of relevant regulatory submission deliverables
- Provide leadership and oversight of all critical global regulatory submissions (pre-IND through post-marketing) to FDA and RoW notified bodies
- Represent the Regulatory department in senior management discussions and present strategies, risk assessments, and recommendations
- Provide hands on leadership for the Regulatory department
Qualifications:
- 15+ years of experience in Regulatory Affairs in biopharma/biotech/pharma
- Advanced degree preferred (MD, PhD, PharmD, MS)
- Previous NDA and small molecule experience is desired
- Has experience managing multiple assets in a product pipeline
- Previous managerial experience is preferred
- Well versed in drug development process and regulatory requirements, as well as a good understanding of the underlying science
- Excellent project management skills, with ability to manage multiple projects and prioritize appropriately
- Ability to rapidly understand & analyze complex problems/situations
- Ability to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed
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