Global Regulatory Strategy Director — Gene Therapy

Arbor-Biotechnologies-Inc; Cambridge (MA); On-site; USD 215,000 - 235,000; Full time

Job summary

Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding submissions, agency meetings, and data narratives.

The role requires a minimum of 10 years in biotech/pharma development with regulatory experience, strong communication, and collaboration with internal and external partners.

Qualifications

• Bachelor’s degree in life sciences required; advanced degree preferred.
• Minimum of 10 years in biotechnology/pharma development with Regulatory Affairs.
• Experience leading FDA interactions and IND submissions preferred.
• Strong written and verbal communication, ability to translate data into regulatory narratives.

Responsibilities

• Lead regulatory strategy and execution across preclinical and early clinical programs.
• Serve as Global Regulatory Lead and point of contact with FDA and other health authorities.
• Draft regulatory submissions, briefing packages, and agency interactions.
• Coordinate with CROs, medical writers, and external consultants to ensure compliant deliverables.

Skills

Regulatory strategy

FDA interactions

Cross-functional leadership

Regulatory guidance

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding submissions, agency meetings, and data narratives.

The role requires a minimum of 10 years in biotech/pharma development with regulatory experience, strong communication, and collaboration with internal and external partners.