Senior Director, Regulatory Affairs - Remote

Overview

The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders, serving as the global regulatory lead for programs.

In Short

• Develop and execute global regulatory strategies.
• Lead regulatory submissions and act as liaison with Health Authorities.
• Provide expert guidance to cross-functional teams.
• Maintain expert knowledge in US and international regulations.
• Support the development of regulatory submission documents.
• Evaluate opportunities for expedited pathways.
• Conduct Health Authority meetings.
• Collaborate with external regulatory experts.
• Perform regulatory strategic assessments for new products.
• Support departmental initiatives and documentation.

Requirements

• Bachelor's degree with a minimum of 10 years in Regulatory Affairs.
• Experience with FDA and other Health Authorities.
• Expert understanding of drug development regulations.
• Strong communication, writing, and presentation skills.
• Demonstrated leadership and problem-solving abilities.
• Strong project management skills.
• Ability to work in a fast-paced environment.
• Experience in rare disease or neurology is a plus.
• Advanced degree (MS, PharmD, PhD) is preferred.
• Strong interpersonal skills for effective collaboration.

Benefits

• Opportunity to work remotely within the United States.
• Play an integral role in global program development.
• Join a growing organization with an expanding pipeline.
• Contribute to elevating patient care.
• Collaborate with a team of dedicated professionals.