Senior Director Regulatory Affairs
📋 Role Overview & Responsibilities
Role:Senior Director, Regulatory Affairs StrategyRemote - USA
Company Description:We are working with a pre-IPO biotech with ~20 full-time employees focused on developing new treatments within the immuno-inflammatory and autoimmune spaces. In addition to excitement that comes with being a pre-IPO biotech, they also have the financial backing of a top 5 global pharma and other commercial-stage biotechs providing them with long-term security.
Role Description:This role is completely remote with irregular travel. The team is looking for a Regulatory professional with a proven track record leading/supporting both FDA and global Regulatory filings across all stages of development. It is key that you have a strong understanding of biologic regulations and have acted as the point of contact for US and international health authorities. Specific experience across autoimmune, immunology/inflammatory diseases is not a “must-have” but would be a great add.
Culture:Energetic, adaptable, and transparent. They have built a team who trust one another and have established an environment where all enjoy showing up to work every day.
Qualifications/Requirements:Bachelor’s degree is required; an advanced degree is preferred.Minimum of 10 years of experience across Regulatory Affairs with a focus in biologic drug developmentStrong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; IND and BLA experience is required.Experience directly interacting with FDA and other global health authorities required.A passion for small, start-up environments.
If interested, please email me at Dakota.Lowe@treblatalent.com
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