Global Regulatory Lead, Gene Therapy Programs

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

Job summary

Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical programs. Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on program teams and as the primary regulatory contact with the FDA and other health authorities.

You will translate strategy into regulatory submissions, briefing materials, and agency interactions, collaborating with internal experts,

Qualifications

• Minimum 10 years in biotech/pharma with regulatory affairs.
• Experience leading FDA interactions and IND submissions.
• Experience with biologics, gene therapy, or gene-editing products.
• Strong written and verbal communication; synthesize data into regulatory narratives.
• Ability to operate independently in a fast-paced early-stage environment.

Responsibilities

• Lead regulatory strategy and execution across development programs.
• Serve as primary regulatory contact with FDA and global authorities.
• Prepare designation applications (Orphan Drug, Rare Pediatric Disease, Fast Track).
• Lead regulatory submissions including INDs and global submissions; coordinate CROs and vendors.
• Provide regulatory guidance to leadership and cross-functional teams; oversee medical writing support.

Skills

Regulatory strategy

FDA interactions

IND submissions

Cross-functional collaboration

Medical writing coordination

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical programs. Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on program teams and as the primary regulatory contact with the FDA and other health authorities.

You will translate strategy into regulatory submissions, briefing materials, and agency interactions, collaborating with internal experts,