Senior Director of Regulatory Affairs - Remote

Overview

A position is immediately available for a Senior Director of Regulatory Affairs to provide strategic leadership and direction for all company regulatory projects and to oversee the execution of activities to support the company's registration goals.

In Short

• Develop long term strategies and execute short term goals for regulatory, clinical and CMC.
• Lead and collaborate with internal teams to ensure compliance with regulatory requirements.
• Prepare regulatory documents including IND submissions and marketing applications.
• Develop robust regulatory strategies and policies.
• Lead regulatory intelligence initiatives.
• Liaise with CMC and clinical teams to meet regulatory requirements.
• Represent regulatory affairs on internal project teams.
• Build and manage a team of regulatory personnel.
• Establish relationships with external regulatory authorities.
• Coordinate global regulatory initiatives.

Requirements

• PhD, M.D. and/or J.D. degree is highly preferred.
• 10+ years regulatory affairs experience in a pharmaceutical or biotech company.
• Technical understanding of cell therapy is required.
• Excellent communication skills and teamwork ability are required.

Benefits

• Opportunity to lead strategic initiatives in a growing company.
• Work in a fully remote environment.
• Collaborate with a diverse team of professionals.