Vice President, Regulatory Affairs

Our client is seeking a Vice President, Regulatory Affairs who will be responsible for regulatory strategy, oversight, and guidance drug development program.  The successful candidate will bring strong leadership abilities to oversee the Regulatory Affairs team, a successful history of effectively leading IND and NDA filings through approval, and interacting effectively with the FDA and other foreign regulatory bodies. 

This position requires a management style of accessibility, mentoring, and setting high standards of performance for the staff.  Solid leadership abilities is critical, along with a history of hiring the right regulatory team members to advance the company goals.  A strategic approach is important, however, this position requires a hands-on operating style, with attention to details, budgets, and timelines.  Reporting directly to the SVP, the principal responsibilities include:

• Direct and manage interactions with FDA and other health authorities
• Direct and manage the preparation, submission, maintenance and expediting of INDs, NDAs, and other regulatory applications
• Lead effective collaborations with other departments to create regulatory documents
• Collaborate with affiliated companies and lead interactions with regulatory authorities

Qualifications:

• PhD or PharmD
• 20+ years of experience in the pharmaceutical industry including at least 15 years in leadership roles in Regulatory Affairs. 
• Oncology experience highly desired
• Solid successful IND and NDA submission expertise along with positive FDA/Regulatory Agency relationships is required
• Excellent written and verbal communication skills
• Experience in a global company, with understanding of international regulatory environments is a plus
• A demonstrated career of high performance in a small company environment is highly desired