Director/Senior Director, Regulatory Affairs Strategist

Maryland - United States

Summary:

We are seeking experienced regulatory affairs professionals with strategic leadership skills and a thorough understanding of global regulatory science in drug development context. This director will serve as the departments subject matter expert for all global Clinical Studies and global submissions (i.e.: IND and NDA, etc.). Seeking strong global expertise, along with proven leadership skills with a successful track record of developing and executing regulatory strategy while working collaboratively cross-functionally with the team. Prior hands-on experience managing and working with these studies and submissions and have had direct interactions with global health authorities is required. Looking for someone that's confident and experienced within regulatory to lead development, as well as, plan, execute, interpret and present all regulatory strategy while working collaboratively and cross-functionally with the team is crucial.

Requirements:

• Master's degree in life sciences or Biology life sciences or equivalent
• Strong knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
• Experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level is required for senior positions.
• Successful track record of direct interactions/leading major global health authorities.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business critical and high-profile development program.
• Key skills: Strategic thinking & influencing, leadership, initiative, management, communication, negotiation and presentation skills.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.