Global Submissions Strategy Director

Scorpion Therapeutics; Boston (MA); On-site; USD 163,000 - 245,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Global Submission Management to orchestrate global regulatory submissions across development and lifecycle programs. This role focuses on Pulmonary or Cell & Gene Therapy areas and partners with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion to align milestones.

The successful candidate will oversee multiple programs, manage risks, and ensure timely, compliant submissions while driving continuous improvement and staff

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or related discipline.
• 7+ years of experience in regulatory submission management/operations or regulatory/clinical project management.
• Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions.

Responsibilities

• Oversee a defined portfolio of regulatory submissions from planning through submission and closeout.
• Develop and maintain submission plans, timelines, and tracking across multiple programs.
• Apply submission management standards, tools, and processes consistently.
• Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables.
• Coordinate cross-functional activities to ensure completeness, quality, and compliance.
• Identify, manage, and resolve operational risks impacting timelines or quality.
• Oversee submission status updates, issue logs, and portfolio-level reporting.
• Lead, coach, and support submission management staff and vendor functional service providers (FSPs).

Skills

Regulatory submissions

Global regulatory knowledge

Project management

Cross-functional leadership

Stakeholder management

AI-driven tools

Education

Bachelor’s degree in Life Sciences or Regulatory Affairs

7+ years regulatory submissions/PM experience

Tools

MS Project

Smartsheet

Veeva RIM

Job description

Scorpion Therapeutics seeks an Associate Director, Global Submission Management to orchestrate global regulatory submissions across development and lifecycle programs. This role focuses on Pulmonary or Cell & Gene Therapy areas and partners with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion to align milestones.

The successful candidate will oversee multiple programs, manage risks, and ensure timely, compliant submissions while driving continuous improvement and staff