Director of Regulatory Affairs - Remote

Overview

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

In Short

• Develop and execute global regulatory strategies.
• Lead regulatory submissions and act as primary liaison with Health Authorities.
• Provide expert guidance to cross-functional teams.
• Maintain expert knowledge in US and international regulations.
• Assess opportunities for expedited pathways and orphan drug designations.
• Conduct Health Authority meetings and prepare regulatory documents.
• Collaborate with external regulatory experts and consultants.
• Support departmental initiatives and process development.
• Demonstrated leadership and problem-solving abilities.
• Excellent communication and project management skills.

Requirements

• Bachelor's degree and a minimum of 8 years of experience in Regulatory Affairs.
• Successful interactions with FDA and other Health Authorities.
• Expert understanding of scientific principles and regulatory requirements.
• Experience in preparation of regulatory filings.
• Strong interpersonal skills and ability to collaborate effectively.
• Demonstrated leadership and teamwork skills.
• Excellent writing and presentation skills.
• Strong project management skills.
• Ability to work in a fast-paced environment.

Benefits

• Opportunity to join a growing organization.
• Play an integral role in global development of programs.
• Work remotely.
• Collaborate with experienced biotech and pharma executives.
• Contribute to transformative medicines for patients.