Senior Director, Regulatory Affairs Liaison – General Medicine

Role Overview

• Oversee the global regulatory strategy development and execution for their assigned programs in the cardiovascular/renal/respiratory therapeutic area to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
• Provide expert advice as the GRL to Early Development Teams (EDT)/Product Development Teams (PDT)and regulatory single point-of-contact for products within and external to Global Regulatory Affairs and Clinical Safety (GRACS) on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Provide leadership by leading the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs which coordinates global, cross-functional regulatory support for development programs and marketed products.
• Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
• Represent our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company teams for meetings with FDA at any phase of drug development
• Coordinate interactions with global regulatory agencies through Regulatory Affairs Europe, Regulatory Affairs International, and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.

Requirements

• Degree in biological science or related discipline
• B.S., with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
• M.S. with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
• M.D. with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
• PhD/PharmD with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
• Ability to achieve optimal results with limited day-to-day direction from the Therapeutic Area Lead
• Outstanding interpersonal, verbal and written communication, and negotiation skills.
• Demonstrated leadership attributes, including experience building and leading high-performing teams.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days