Global Regulatory Submissions Strategy Director

Scorpion Therapeutics; Boston (MA); On-site; USD 190,000 - 286,000; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

Job summary

Scorpion Therapeutics is seeking a Director of Global Submission Management to provide strategic oversight and execution of a portfolio of regulatory submissions across development and lifecycle programs.

You will lead submission planning, timelines, and cross-functional collaboration to ensure timely, compliant registrations across global programs and markets. The role emphasizes staff leadership, process standardization, and the integration of emerging technologies to optimize submissions.

Qualifications

• Bachelor’s degree required in Life Sciences, Regulatory Affairs or related field.
• 10+ years of leadership experience across submission portfolios.
• Experience with routine, regional and lifecycle submissions in matrixed environments.

Responsibilities

• Oversee a defined portfolio of regulatory submissions from planning through closeout.
• Develop and maintain submission plans, timelines, and tracking across multiple programs.
• Coordinate cross-functional activities to ensure completeness, quality, and compliance.
• Lead, coach, and support submission management staff and vendor FSPs.
• Drive continuous improvement and knowledge sharing; adopt emerging technologies (incl. AI).

Skills

Regulatory submissions

Project management

Cross-functional coordination

Risk management

Education

Bachelor’s degree in Life Sciences/Regulatory Affairs/Project Management or related field

Tools

MS Project

Smartsheet

Veeva RIM

Job description

Scorpion Therapeutics is seeking a Director of Global Submission Management to provide strategic oversight and execution of a portfolio of regulatory submissions across development and lifecycle programs.

You will lead submission planning, timelines, and cross-functional collaboration to ensure timely, compliant registrations across global programs and markets. The role emphasizes staff leadership, process standardization, and the integration of emerging technologies to optimize submissions.