Vice President, Regulatory Affairs - Remote

Overview

The Vice President, Regulatory Affairs will report to the Chief Development Officer and help forward the mission by leading the execution of global regulatory strategies across our multiple late-stage programs. This is a hands-on role that requires a strong working knowledge of regulatory procedures and a proven track record leading successful NDA submissions.

In Short

• Oversee global regulatory strategy and submissions
• Lead a team for regulatory strategy and approvals
• Act as regulatory lead for the company's first NDA
• Drive preparation and submission of regulatory filings
• Identify opportunities for accelerated development approaches
• Draft and submit documentation for INDs, CTAs, NDAs, and MAAs
• Manage external regulatory writing support
• Serve as FDA and EMA liaison
• Maintain knowledge of regulatory requirements
• Collaborate effectively in a fast-paced environment

Requirements

• 12+ years of biopharma Regulatory Affairs experience
• PharmD, PhD, or MD preferred
• Track record of successful NDA submissions
• Experience with global pharmacovigilance principles
• Must have small company experience
• Knowledge of GxP regulations and ICH guidelines
• Experience with expedited pathways
• Desire to be part of a creative regulatory organization
• Strong communication and problem-solving skills
• Ability to work under pressure

Benefits

• Opportunity to lead regulatory strategies
• Work in an innovative and agile environment
• Collaborate with cross-functional teams
• Contribute to the approval of novel therapies
• Engage with regulatory agencies
• Drive strategic value through creative approaches