Global Regulatory Strategy Director – Lead Complex Programs

Scorpion Therapeutics

Washington (District of Columbia)

On-site

USD 150,000 - 230,000

Full time

14 days+

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Job summary

Scorpion Therapeutics in Washington, DC, seeks a senior Regulatory Affairs leader to drive strategy for complex development programs from first-in-human to post-marketing. You will represent GRA on core project teams and align regulatory input with clinical and commercial objectives.

Leading global regulatory strategies, mentoring staff, and guiding cross-functional teams will be central to this role. You will influence policy, improve processes, and ensure timely regulatory submissions across

Qualifications

Bachelor's degree required; typically 12+ years in pharma/biotech regulatory affairs.
5+ years supervisory/management experience.
Experience leading regulatory strategy for development programs from FIH to post-marketing.

Responsibilities

Lead development of regulatory strategy for development projects (F IH to post-marketing).
Represent GRA on core/project teams; align with regional leaders for clinical programs and commercial strategy.
Provide guidance on global regulatory strategies, tactics, procedures, and practices to cross-functional teams and senior management.
Develop and manage project plans and timelines; assign/manage resources to meet goals on time.
Influence regulatory environment via conferences, agency meetings, committees, and trade associations; stay current on regulations and policy.