Global Regulatory Lead, Gene Editing Programs

Arbor Biotechnologies; Cambridge (MA); Vor Ort; USD 215.000 - 235.000; Vollzeit

Zusammenfassung

Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead global regulatory strategy across our preclinical and early clinical portfolio, reporting to the Chief Medical Officer.

You will be the primary regulatory contact with FDA and other health authorities, drive designations, plan submissions, and coordinate CROs, medical writers, and consultants to align with development plans.

Qualifikationen

• Bachelor's degree in life sciences required; advanced degree preferred.
• Minimum 10 years in biotech/pharma regulatory affairs.
• Experience leading regulatory strategy, submissions, and health authority interactions.
• FDA interactions and IND submissions experience preferred.
• Experience with biologics, gene therapy, or gene editing products.

Aufgaben

• Lead regulatory strategy and program engagement across the portfolio.
• Serve as the primary regulatory contact with FDA and global authorities.
• Author designation applications and manage submissions and designations.
• Oversee lifecycle management, including annual reports and DSURs.
• Coordinate with CROs, medical writers, and external vendors.

Kenntnisse

Regulatory strategy

FDA interactions

IND submissions

Cross-functional leadership

Regulatory writing

Ausbildung

Bachelor's degree in life sciences

Advanced degree preferred

Jobbeschreibung

Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead global regulatory strategy across our preclinical and early clinical portfolio, reporting to the Chief Medical Officer.

You will be the primary regulatory contact with FDA and other health authorities, drive designations, plan submissions, and coordinate CROs, medical writers, and consultants to align with development plans.