Director, Global Submission Management

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

General Summary:

The Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs, including planning, submission, and closeout, to enable and advance global product registrations.

Key Duties And Responsibilities:

• Oversee a defined portfolio of regulatory submissions from planning through closeout
• Develop and maintain submission plans, timelines, and tracking across multiple programs
• Ensure consistent use of submission management standards, tools, and processes
• Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define scope, milestones, and deliverables
• Coordinate cross-functional activities to ensure completeness, quality, and compliance
• Identify, manage, and resolve operational risks; escape when thresholds are reached
• Oversee status updates, issue logs, and portfolio-level reporting
• Support workload planning and capacity management
• Lead, coach, and support submission management staff and vendor FSPs
• Drive continuous improvement and knowledge sharing; adopt emerging technologies (incl. AI)

Knowledge And Skills:

• Strong knowledge of global regulatory submission requirements, processes, and timelines
• Experience with submission/project management tools; manage multiple concurrent submissions
• Organizational, problem-solving, and cross-functional stakeholder management skills

Education And Experience:

• Bachelor’s degree in Life Sciences/Regulatory Affairs/Project Management or related field
• 10+ years relevant experience with leadership across submission portfolios
• Experience across routine, regional, and lifecycle submissions; matrixed environments
• People-management experience; MS Project, Smartsheet, Veeva RIM

Pay Range:

• $190,400 - $285,600; eligible for annual bonus and annual equity awards.